N O T I C E S O F C O M P L I A N C E PRESCRIPTION PRODUCTS FOR HUMAN USE January - December 1992 ----------------------------------------------------------------- Brand Name: Accupril Source: Parke-Davis Active Ingredient: Quinapril hydrochloride Comments: Tab (5, 10, 20, 40 mg) Orl Date: 92-01-14 ----------------------------------------------------------------- Brand Name: Accupril Tablets Source: Parke-Davis Active Ingredient: Quinapril hydrochloride Comments: Revised product monograph Date: 92-07-13 ----------------------------------------------------------------- Brand Name: Accutane Source: Hoffmann-La Roche Active Ingredient: Isotretinoin Comments: New packaging, new expiration date Date: 92-05-21 ----------------------------------------------------------------- Brand Name: Acular Source: Allergan Active Ingredient: Ketorolac Tromethamine Comments: Liq (0.5%) Oph Date: 92-02-12 ----------------------------------------------------------------- Brand Name: Adalat XL Source: Miles Active Ingredient: Nifedipine Comments: New dosage form Date: 92-03-26 ----------------------------------------------------------------- Brand Name: Adenoscan Source: Fujisawa Active Ingredient: Adenosine Comments: LIQ (3 mg/mL) IV Date: 92-10-19 ----------------------------------------------------------------- Brand Name: Adenoscan Source: Medco Active Ingredient: Adenosine Comments: LIQ (3 mg/mL) IV Date: 92-10-21 ----------------------------------------------------------------- Brand Name: Adriamycin PFS Source: Adria Laboratories Active Ingredient: Doxorubicin hydrochloride Comments: New packaging Date: 92-04-09 ----------------------------------------------------------------- Brand Name: Adriamycin RDF Source: Adria Active Ingredient: Doxorubicin hydrochloride Comments: Revised product monograph Date: 92-02-27 ----------------------------------------------------------------- Brand Name: Ak-Baclo Source: Akorn Active Ingredient: Baclofen Comments: TAB (10, 20 mg) ORL Date: 92-10-19 ----------------------------------------------------------------- Brand Name: Ak-Glyb Source: Akorn Active Ingredient: Glyburide Comments: TAB (5.0, 2.5 mg) ORL Date: 92-10-19 ----------------------------------------------------------------- Brand Name: Ak-Nifed Source: Akorn Active Ingredient: Nifedipine Comments: CAP (10 mg) ORL Date: 92-10-19 ----------------------------------------------------------------- Brand Name: Ak-Tamox Source: Akorn Active Ingredient: Tamoxifen citrate Comments: TAB (10, 20 mg) ORL Date: 92-10-19 ----------------------------------------------------------------- Brand Name: Albert Pentoxifylline Source: Albert Pharma Active Ingredient: Pentoxifylline Comments: SRT (400 mg) Orl Date: 92-02-12 ----------------------------------------------------------------- Brand Name: Aldactone Source: Searle Active Ingredient: Spironolactone Comments: Revised product monograph Date: 92-11-17 ----------------------------------------------------------------- Brand Name: Alfenta Source: Janssen Active Ingredient: Alfentanil hydrochloride Comments: New indication Date: 92-03-24 ----------------------------------------------------------------- Brand Name: Alomide Source: Alcon Active Ingredient: Lodoxamide tromethamine Comments: Alternate source of active ingredient Date: 92-03-26 ----------------------------------------------------------------- Brand Name: Alpha-Tamoxifen Source: Genpharm Active Ingredient: Tamoxifen citrate Comments: Alternate source of active ingredient Date: 92-10-09 ----------------------------------------------------------------- Brand Name: Aminosyn II with Electrolytes (7, 8.5, 10 %) / Lyposyn II (10, 20 %) / Dextrose (50 %) Source: Abbott Active Ingredient: Amino acids with electrolytes / fat emulsion / dextrose Comments: LIQ (7, 8.5, 10 / 10, 20 / 50 %) IV Date: 92-09-11 ----------------------------------------------------------------- Brand Name: Aminosyn-HBC Source: Abbott Active Ingredient: Amino acids Comments: Change in formulation Date: 92-02-27 ----------------------------------------------------------------- Brand Name: Aminosyn-PF Source: Abbott Active Ingredient: Amino acids Comments: Change in formulation Date: 92-02-27 ----------------------------------------------------------------- Brand Name: Anandron Source: Hoechst-Roussel Active Ingredient: Nilutamide Comments: TAB (50, 100 mg) ORL Date: 92-06-18 ----------------------------------------------------------------- Brand Name: Anaprox Tablets Source: Syntex Active Ingredient: Naproxen sodium Comments: Change in formulation, revised product monograph Date: 92-03-25 ----------------------------------------------------------------- Brand Name: Andriol Source: Organon Active Ingredient: Testosterone undecanoate Comments: Cap (40 mg) Oral Date: 92-03-30 ----------------------------------------------------------------- Brand Name: Apo-Atenol Source: Apotex Active Ingredient: Atenolol Comments: Alternate source of active ingredient Date: 92-06-25 ----------------------------------------------------------------- Brand Name: Apo-Capto Source: Apotex Active Ingredient: Captopril Comments: New strength Date: 92-09-11 ----------------------------------------------------------------- Brand Name: Apo-Capto Tab (12.5, 25, 50, 100 mg) Source: Apotex Active Ingredient: Captopril Comments: Change in formulation and in manufacturing Date: 92-07-10 ----------------------------------------------------------------- Brand Name: Apo-Capto Tablets Source: Apotex Active Ingredient: Captopril Comments: Revised product monograph Date: 92-07-13 ----------------------------------------------------------------- Brand Name: Apo-Dipyridamole Source: Apotex Active Ingredient: Dipyridamole Comments: Tab (20, 50, 75 mg) Oral Date: 92-04-21 ----------------------------------------------------------------- Brand Name: Apo-Flurbiprofen Source: Apotex Active Ingredient: Flurbiprofen Comments: Alternate source of active ingredient Date: 92-11-03 ----------------------------------------------------------------- Brand Name: Apo-Procainamide Hydrochloride Source: Apotex Active Ingredient: Procainamide hydrochloride Comments: Revised product monograph Date: 92-01-29 ----------------------------------------------------------------- Brand Name: Apo-Ranitidine Source: Apotex Active Ingredient: Ranitidine hydrochloride Comments: Alternate source of active ingredient Date: 92-04-09 ----------------------------------------------------------------- Brand Name: Apo-Triazo Source: Apotex Active Ingredient: Triazolam Comments: Revised product monograph Date: 92-03-19 ----------------------------------------------------------------- Brand Name: Apo-Triazo Source: Apotex Active Ingredient: Triazolam Comments: New packaging Date: 92-07-24 ----------------------------------------------------------------- Brand Name: Apo-Zidovudine Source: Apotex Active Ingredient: Zidovudine Comments: CAP (100 mg) Oral Date: 92-05-25 ----------------------------------------------------------------- Brand Name: Aredia Source: Geigy Active Ingredient: Pamidronate disodium Comments: LIQ (3 mg/mL) IV Infusion Date: 92-02-26 ----------------------------------------------------------------- Brand Name: Asacol Source: Proctor & Gamble Active Ingredient: Mesalamine Comments: ECC (400 mg) ORL Date: 92-08-13 ----------------------------------------------------------------- Brand Name: Atrovent Source: Boehringer Ingelheim Active Ingredient: Ipratropium bromide Comments: Change in manufacturing Date: 92-06-02 ----------------------------------------------------------------- Brand Name: Berotec Source: Boehringer Ingelheim Active Ingredient: Fenoterol hydrobromide Comments: New strength Date: 92-09-11 ----------------------------------------------------------------- Brand Name: Betoptic S Source: Alcon Active Ingredient: Betaxolol hydrochloride Comments: New dosage form Date: 92-10-08 ----------------------------------------------------------------- Brand Name: Biaxin Source: Abbott Active Ingredient: Clarithromycin Comments: Tab (250 mg) Oral Date: 92-05-08 ----------------------------------------------------------------- Brand Name: Biquin Durules Source: Astra Pharma Active Ingredient: Quinidine bisulfate Comments: Revised product monograph Date: 92-03-09 ----------------------------------------------------------------- Brand Name: Bonefos Source: Rhone-Poulenc Active Ingredient: Clodronate disodium Comments: Cap (400 mg) Oral Date: 92-05-11 ----------------------------------------------------------------- Brand Name: Bonefos Source: Rhone-Poulenc Active Ingredient: Clodronate disodium Comments: Liq (60 mg/mL) IV Date: 92-05-11 ----------------------------------------------------------------- Brand Name: Brevibloc Source: Du Pont Pharma Active Ingredient: Esmolol hydrochloride Comments: Liq (10, 100, 200 mg/mL) IV Date: 92-01-24 ----------------------------------------------------------------- Brand Name: Burinex Source: Leo Active Ingredient: Bumetanide Comments: TAB (1, 5 mg) Oral Date: 92-02-26 ----------------------------------------------------------------- Brand Name: Buspar Source: Bristol Active Ingredient: Buspirone hydrochloride Comments: Change in packaging Date: 92-12-17 ----------------------------------------------------------------- Brand Name: Caltine Source: Ferring Active Ingredient: Salcatonin Comments: LIQ (100 IU/mL) IV, SC Date: 92-07-30 ----------------------------------------------------------------- Brand Name: Capoten Tablets Source: Squibb Active Ingredient: Captopril Comments: Revised product monograph Date: 92-07-13 ----------------------------------------------------------------- Brand Name: Capozide Source: Squibb Active Ingredient: Captopril/Hydrochlorothiazide Comments: Revised product monograph Date: 92-07-13 ----------------------------------------------------------------- Brand Name: Capozide Source: Squibb Active Ingredient: Captopril / Hydrochlorothiazide Comments: New strength Date: 92-12-17 ----------------------------------------------------------------- Brand Name: Carbolith Source: ICN Canada Active Ingredient: Lithium carbonate Comments: Revised product monograph Date: 92-08-26 ----------------------------------------------------------------- Brand Name: Carbolith Cap 600 mg Source: ICN Canada Active Ingredient: Lithium carbonate Comments: New strength Date: 92-11-16 ----------------------------------------------------------------- Brand Name: Carbolith Capsule (150, 300, 600 mg) Source: ICN Active Ingredient: Lithium carbonate Comments: New source of active ingredient Date: 92-12-17 ----------------------------------------------------------------- Brand Name: Carboplatin Source: David Bull Active Ingredient: Carboplatin Comments: LIQ, PWS (10 mg/mL, 150 mg/vial) I.V. Date: 92-07-06 ----------------------------------------------------------------- Brand Name: Cardizem CD Source: Nordic Active Ingredient: Diltiazem hydrochloride Comments: New dosage form Date: 92-10-02 ----------------------------------------------------------------- Brand Name: Cardura Source: Pfizer Active Ingredient: Doxazosin mesylate Comments: New expiration date Date: 92-06-19 ----------------------------------------------------------------- Brand Name: Ceftin Source: Glaxo Active Ingredient: Cefuroxime axetil Comments: New dosage form, new indication Date: 92-11-25 ----------------------------------------------------------------- Brand Name: Ceftin Tablets Source: Glaxo Active Ingredient: Cefuroxime axetil Comments: New indication Date: 92-07-07 ----------------------------------------------------------------- Brand Name: Ceptaz Source: Glaxo Active Ingredient: Ceftazidime Comments: PWS (500 mg, 1 g/vial) IM, IV; (2 g, 10 g/vial) IV Date: 92-02-27 ----------------------------------------------------------------- Brand Name: Choloxin Source: Boots Active Ingredient: Sodium dextrothyronine Comments: TAB (4 mg) Orl Date: 92-02-19 ----------------------------------------------------------------- Brand Name: Choloxin Source: Boots Active Ingredient: Sodium dextrothyronine Comments: TAB (2 mg) Orl Date: 92-02-19 ----------------------------------------------------------------- Brand Name: Chymodiactin Source: Boots Active Ingredient: Chymopapaine Comments: LIQ (4.0 NKAT/2 mL) IND Date: 92-02-19 ----------------------------------------------------------------- Brand Name: Cidomycin Source: Roussel Active Ingredient: Gentamicin sulphate Comments: Change in formulation Date: 92-02-12 ----------------------------------------------------------------- Brand Name: Cidomycin Injection Source: Hoechst-Roussel Active Ingredient: Gentamicin sulfate Comments: LIQ (10, 40 mg/mL) IM, IV Date: 92-06-18 ----------------------------------------------------------------- Brand Name: Ciloxan Source: Alcon Active Ingredient: Ciprofloxacin hydrochloride Comments: LIQ (0.3%) Oph Date: 92-03-17 ----------------------------------------------------------------- Brand Name: Cipro I.V. Source: Miles Active Ingredient: Ciprofloxacin Comments: Change in manufacturing Date: 92-08-12 ----------------------------------------------------------------- Brand Name: Cipro Tablets Source: Miles Active Ingredient: Ciprofloxacin hydrochloride Comments: Change in manufacturing Date: 92-08-12 ----------------------------------------------------------------- Brand Name: Cisplatin Source: David Bull Labs Active Ingredient: Cisplatin Comments: Change in formulation Date: 92-05-25 ----------------------------------------------------------------- Brand Name: Claforan Source: Hoechst-Roussel Active Ingredient: Cefotaxime sodium Comments: Change in manufacturer's name Date: 92-06-25 ----------------------------------------------------------------- Brand Name: Claforan Source: Hoechst-Roussel Active Ingredient: Cefotaxime sodium Comments: Change in manfuacturing Date: 92-10-02 ----------------------------------------------------------------- Brand Name: Clindamycin Phosphate Injection USP Source: Kenral Active Ingredient: Clindamycin Phosphate Comments: Change in formulation, change in packaging Date: 92-01-13 ----------------------------------------------------------------- Brand Name: Clozaril Source: Sandoz Active Ingredient: Clozapine Comments: New expiration date Date: 92-08-27 ----------------------------------------------------------------- Brand Name: Cyclen Source: Ortho-McNeil Active Ingredient: Norgestimate/Ethinyl estradiol Comments: TAB (0.25/0.035 mg) ORAL Date: 92-07-06 ----------------------------------------------------------------- Brand Name: Cytarabine Injection Source: David Bull Laboratories Active Ingredient: Cytarabine Comments: Revised product monograph, new packaging Date: 92-04-03 ----------------------------------------------------------------- Brand Name: Cytotec Source: Searle Active Ingredient: Misoprostol Comments: Revised product monograph Date: 92-06-25 ----------------------------------------------------------------- Brand Name: Cytoxan Source: Bristol Active Ingredient: Cyclophosphamide Comments: New strength Date: 92-07-09 ----------------------------------------------------------------- Brand Name: Dantrium Capsules Source: Proctor & Gamble Active Ingredient: Dantrolene sodium Comments: CAP (25, 100 mg) ORL Date: 92-08-13 ----------------------------------------------------------------- Brand Name: Dantrium Intravenous Source: Proctor & Gamble Active Ingredient: Dantrolene sodium Comments: PWS (20 mg) IV Date: 92-08-13 ----------------------------------------------------------------- Brand Name: Dermasone Source: Technilab Active Ingredient: Clobetasol 17-propionate Comments: CRM, ONT, LOT (0.05 %) TOP Date: 92-08-27 ----------------------------------------------------------------- Brand Name: Dermazin Source: Pharmascience Active Ingredient: Silver sulfadiazine Comments: CRM (1 %) TOP Date: 92-10-27 ----------------------------------------------------------------- Brand Name: Desferal Source: Ciba Active Ingredient: Deferoxamine mesylate Comments: New indication, new route of administration Date: 92-03-24 ----------------------------------------------------------------- Brand Name: Desipramine Hydrochloride Tablets Source: JCP Laboratories Active Ingredient: Desipramine Comments: TAB (10, 25, 50, 75, 100, 150 mg) ORAL Date: 92-08-19 ----------------------------------------------------------------- Brand Name: Diaburide Source: Technilab Active Ingredient: Glyburide Comments: TAB (2.5, 5.0 mg) ORL Date: 92-07-09 ----------------------------------------------------------------- Brand Name: Didronel Source: Proctor & Gamble Active Ingredient: Etidronate disodium Comments: TAB (200, 400 mg) ORL Date: 92-08-13 ----------------------------------------------------------------- Brand Name: Diflucan Source: Pfizer Active Ingredient: Fluconazole Comments: Change in manufacturing site, new expiration date Date: 92-06-25 ----------------------------------------------------------------- Brand Name: Dipentum Source: Kabi Active Ingredient: Olsalazine sodium Comments: CAP (250 mg) ORL Date: 92-09-21 ----------------------------------------------------------------- Brand Name: Diprivan Source: I.C.I. Pharma Active Ingredient: Propofol Comments: New indication Date: 92-10-07 ----------------------------------------------------------------- Brand Name: Diprivan Source: I.C.I. Pharma Active Ingredient: Propofol Comments: Revised product monograph Date: 92-10-27 ----------------------------------------------------------------- Brand Name: Dolobid Source: Frosst Active Ingredient: Diflunisal Comments: Change in manufacturing Date: 92-02-24 ----------------------------------------------------------------- Brand Name: Dolobid Tablets Source: Frosst Active Ingredient: Diflunisal Comments: New packaging Date: 92-10-20 ----------------------------------------------------------------- Brand Name: Dopamine Hydrochloride and Dextrose Source: Abbott Active Ingredient: Dopamine hydrochloride, dextrose Comments: Change in packaging Date: 92-04-28 ----------------------------------------------------------------- Brand Name: Dovonex Source: Leo Laboratories Active Ingredient: Calcipotriol Comments: ONT (50 mcg/g) TOP Date: 92-10-27 ----------------------------------------------------------------- Brand Name: Duralith Source: McNeil Active Ingredient: Lithium carbonate Comments: New dosage regimen, revised product monograph Date: 92-10-07 ----------------------------------------------------------------- Brand Name: Ecostatin Source: Squibb Canada Active Ingredient: Econazole nitrate Comments: Change in manufacturing, alternate source of finished product Date: 92-10-02 ----------------------------------------------------------------- Brand Name: Ecostatin Source: Westwood Squibb Active Ingredient: Econazole nitrate Comments: SUP (150 mg) VAG Date: 92-10-19 ----------------------------------------------------------------- Brand Name: Ecostatin Cream 1.0 % Source: Westwood-Squibb Active Ingredient: Econazole Nitrate Comments: CRM (1.0 %) TOP Date: 92-11-19 ----------------------------------------------------------------- Brand Name: Edecrin Tablets and Sodium Edecrin for Injection Source: Merck Sharp & Dohme Active Ingredient: Ethacrynic acid, ethacrynate sodium Comments: Change in manufacturing Date: 92-07-07 ----------------------------------------------------------------- Brand Name: Eldepryl Source: Deprenyl Active Ingredient: Selegiline hydrochloride Comments: New indication Date: 92-04-15 ----------------------------------------------------------------- Brand Name: Emcyt Source: Kabi Pharmacia Active Ingredient: Estramustine sodium phosphate Comments: CAP (140 mg) ORL Date: 92-07-09 ----------------------------------------------------------------- Brand Name: Emcyt Source: Kabi Active Ingredient: Estramustine phosphate sodium Comments: Change in manufacturing site, new expiration date Date: 92-12-07 ----------------------------------------------------------------- Brand Name: Entex LA Source: Proctor & Gamble Active Ingredient: Phenylpropanolamine hydrochloride / Guaifenesin Comments: SRT (75 / 600 mg) ORL Date: 92-08-13 ----------------------------------------------------------------- Brand Name: Ergamisol Source: Janssen Active Ingredient: Levamisole hydrochloride Comments: New indication Date: 92-02-07 ----------------------------------------------------------------- Brand Name: Erycidin Source: Stiefel Active Ingredient: Erythromycin / ethyl alcohol Comments: LOT (2 % / 72 %) TOP Date: 92-10-29 ----------------------------------------------------------------- Brand Name: Estraderm Source: CIBA Active Ingredient: Estradiol - 17B Comments: New indication Date: 92-02-17 ----------------------------------------------------------------- Brand Name: Exosurf Source: Wellcome Active Ingredient: Colfosceril palmitate Comments: New packaging Date: 92-02-27 ----------------------------------------------------------------- Brand Name: Feldene Source: Pfizer Active Ingredient: Piroxicam Comments: Alternate source of active ingredient Date: 92-04-01 ----------------------------------------------------------------- Brand Name: Fentanyl Citrate Source: David Bull Active Ingredient: Fentanyl citrate Comments: LIQ (50 mcg/mL) IV, IM, EPD Date: 92-06-04 ----------------------------------------------------------------- Brand Name: Floxin Source: Ortho-McNeil Active Ingredient: Ofloxacin Comments: Tab (200 mg) Orl Date: 92-02-12 ----------------------------------------------------------------- Brand Name: Floxin Source: Ortho-McNeil Active Ingredient: Ofloxacin Comments: Tab (400 mg) Orl Date: 92-02-12 ----------------------------------------------------------------- Brand Name: Floxin Source: Ortho-McNeil Active Ingredient: Ofloxacin Comments: Tab (300 mg) Orl Date: 92-02-12 ----------------------------------------------------------------- Brand Name: Fludara Source: Berlex Active Ingredient: Fludarabine phosphate Comments: PWS (50 mg/vial) IV Date: 92-06-16 ----------------------------------------------------------------- Brand Name: Fluoroplex Source: Herbert Laboratories Active Ingredient: Fluorouracil Comments: Liq (1.0%) Top Date: 92-02-12 ----------------------------------------------------------------- Brand Name: Fluoroplex Cream Source: Allergan Herbert Active Ingredient: Fluorouracil Comments: CRM (1%) TOP Date: 92-04-29 ----------------------------------------------------------------- Brand Name: Fluoroplex Topical Solution Source: Allergan Herbert Active Ingredient: Fluorouracil Comments: LIQ (1%) TOP Date: 92-04-29 ----------------------------------------------------------------- Brand Name: Fluorouracil Source: David Bull Active Ingredient: Fluorouracil Comments: LIQ (50 mg/mL) IV Date: 92-09-02 ----------------------------------------------------------------- Brand Name: Flurbiprofen Source: Kenral Active Ingredient: Flurbiprofen Comments: Revised product monograph Date: 92-02-19 ----------------------------------------------------------------- Brand Name: Frisium Source: Hoechst-Roussel Active Ingredient: Clobazam Comments: TAB (10 mg) ORL Date: 92-06-18 ----------------------------------------------------------------- Brand Name: Froben SR Source: Organon Active Ingredient: Flurbiprofen Comments: New packaging Date: 92-02-07 ----------------------------------------------------------------- Brand Name: Fucidin Tablets Source: Leo Laboratories Active Ingredient: Sodium fusidate Comments: New packaging Date: 92-05-21 ----------------------------------------------------------------- Brand Name: Ganite Source: Fujisawa Pharmaceutical Active Ingredient: Gallium nitrate Comments: LIQ (25 mg/mL) I.V. Date: 92-06-02 ----------------------------------------------------------------- Brand Name: Gen-Cefazolin Source: Genpharm Active Ingredient: Cefazolin sodium Comments: PWS (0.5, 1 g/vial) IM, IV; PWS (10 g/vial) IV Date: 92-09-02 ----------------------------------------------------------------- Brand Name: Gen-Glybe Source: Genpharm Active Ingredient: Glyburide Comments: Change in manufacturing Date: 92-11-17 ----------------------------------------------------------------- Brand Name: Gen-Salbutamol Sterinebs Source: Genpharm Active Ingredient: Salbutamol sulfate Comments: New dosage form Date: 92-09-24 ----------------------------------------------------------------- Brand Name: Gen-Timolol Source: Genpharm Active Ingredient: Timolol maleate Comments: Liq (0.25%, 0.5%) Opt Date: 92-04-28 ----------------------------------------------------------------- Brand Name: Gen-Triazolam Tab 0.125, 0.25 mg Source: Genpharm Active Ingredient: Triazolam Comments: New packaging, change in formulation Date: 92-11-25 ----------------------------------------------------------------- Brand Name: Gen-Triazolam Tablet Source: Genpharm Active Ingredient: Triazolam Comments: TAB (0.125, 0.25 mg) ORAL Date: 92-08-05 ----------------------------------------------------------------- Brand Name: Gentamicin Sulfate Source: Abbott Active Ingredient: Gentamicin sulfate Comments: Change in packaging Date: 92-11-17 ----------------------------------------------------------------- Brand Name: Habitrol Source: Ciba Active Ingredient: Nicotine Comments: Patch (7, 14, 21 mg/day) TRD Date: 92-05-12 ----------------------------------------------------------------- Brand Name: Halcicomb Source: Squibb Active Ingredient: Halcinonide, nystatin, neomycin sulfate Comments: Change in manufacturing, change in manufacturing site Date: 92-04-28 ----------------------------------------------------------------- Brand Name: Halcicomb Source: Westwood Squibb Active Ingredient: Halcinonide / Nystatin / Neomycin sulfate Comments: CRM (1.0 mg / 100,000 units / 2.5 mg) TOP Date: 92-10-19 ----------------------------------------------------------------- Brand Name: Halcion Source: UpJohn Active Ingredient: Triazolam Comments: Revised product monograph Date: 92-03-19 ----------------------------------------------------------------- Brand Name: Halog Source: Squibb Canada Active Ingredient: Halcinonide Comments: Change in formulation, change in manufacturing Date: 92-10-05 ----------------------------------------------------------------- Brand Name: Halog Source: Westwood Squibb Active Ingredient: Halcinonide Comments: CRM (0.025 %) TOP, ONT (0.1 %) TOP, LIQ (0.1 %) TOP Date: 92-10-19 ----------------------------------------------------------------- Brand Name: Halog Cream 0.1 % Source: Westwood-Squibb Active Ingredient: Halcinonide Comments: CRM (0.1 %) TOP Date: 92-11-19 ----------------------------------------------------------------- Brand Name: Heparin Sodium and 5 % Dextrose Injection Source: Baxter Active Ingredient: Heparin sodium, dextrose Comments: New strength Date: 92-09-28 ----------------------------------------------------------------- Brand Name: HIVID Source: Hoffmann-La Roche Active Ingredient: Zalcitabine Comments: TAB (0.375, 0.75 mg) ORAL Date: 92-07-07 ----------------------------------------------------------------- Brand Name: Hytrin Source: Abbott Active Ingredient: Terazosin hydrochloride Comments: New strength, revised specification Date: 92-02-07 ----------------------------------------------------------------- Brand Name: Imitrex Source: Glaxo Active Ingredient: Sumatriptan succinate Comments: Tab (100 mg) Orl; Liq (6 mg/0.5 mL) SC Date: 92-01-20 ----------------------------------------------------------------- Brand Name: Indotec Source: Technilab Active Ingredient: Indomethacin Comments: SUP (50, 100 mg) RT Date: 92-12-22 ----------------------------------------------------------------- Brand Name: Intal Source: Fisons Active Ingredient: Sodium cromoglycate Comments: New packaging Date: 92-02-28 ----------------------------------------------------------------- Brand Name: Intralipid Source: Kabi Active Ingredient: Soybean oil / Egg phospholipids / Glycerine Comments: EML (10, 20%) IV Date: 92-09-21 ----------------------------------------------------------------- Brand Name: Iopidine Source: Alcon Active Ingredient: Apraclonidine hydrochloride Comments: Liq (1% as apraclonidine) Oph Date: 92-03-25 ----------------------------------------------------------------- Brand Name: Isoptin SR Source: Searle Active Ingredient: Verapamil hydrochloride Comments: New strength Date: 92-08-12 ----------------------------------------------------------------- Brand Name: Keflin Source: Eli Lilly Active Ingredient: Cephalothin sodium Comments: Change in manufacturing Date: 92-04-01 ----------------------------------------------------------------- Brand Name: Kefurox Source: Eli Lilly Active Ingredient: Cefuroxime sodium Comments: Revised specification Date: 92-04-01 ----------------------------------------------------------------- Brand Name: Kefurox Source: Eli Lilly Active Ingredient: Cefuroxime sodium Comments: New strength Date: 92-05-21 ----------------------------------------------------------------- Brand Name: Kefzol Source: Eli Lilly Active Ingredient: Cefazolin sodium Comments: Revised specification Date: 92-04-01 ----------------------------------------------------------------- Brand Name: Leucovorin Calcium Source: Lederle Active Ingredient: Calcium folinate Comments: Revised product monograph Date: 92-10-29 ----------------------------------------------------------------- Brand Name: Leucovorin Calcium Injection Source: David Bull Active Ingredient: Leucovorin Calcium Comments: Liq (3, 10 mg/mL) IM, IV Date: 92-05-12 ----------------------------------------------------------------- Brand Name: Lithane Source: Pfizer Active Ingredient: Lithium carbonate Comments: New strength Date: 92-11-30 ----------------------------------------------------------------- Brand Name: Loprox Source: Hoechst-Roussel Active Ingredient: Ciclopirox olamine Comments: Change in formulation Date: 92-06-25 ----------------------------------------------------------------- Brand Name: Losec Source: Astra Active Ingredient: Omeprazole Comments: Change in manufacturing Date: 92-12-17 ----------------------------------------------------------------- Brand Name: Lupron Depot Source: Tap Pharmaceuticals Active Ingredient: Leuprolide acetate Comments: New strength, new indication Date: 92-09-28 ----------------------------------------------------------------- Brand Name: M.T.E.-6, M.T.E.-6 Concentrated Source: Lyphomed Active Ingredient: Zinc sulfate / Cupric sulfate / Manganese sulfate / Chromic chloride / Selenious acid / Sodium iodide Comments: LIQ (5 / 1 / 0.5 / 0.01 / 0.06 / 0.075 mg/mL) IV Date: 92-08-06 ----------------------------------------------------------------- Brand Name: Macrodantin Source: Proctor & Gamble Active Ingredient: Nitrofurantoin Comments: CAP (25, 50, 100 mg) ORL Date: 92-08-13 ----------------------------------------------------------------- Brand Name: Magnevist Source: Berlex Active Ingredient: Gadopentetate dimeglumine Comments: LIQ (469 mg/mL) IV Date: 92-06-22 ----------------------------------------------------------------- Brand Name: Mandol Source: Eli Lilly Active Ingredient: Cefamandole nafate Comments: Change in manufacturing Date: 92-04-01 ----------------------------------------------------------------- Brand Name: Manerix Source: Hoffmann-La Roche Active Ingredient: Moclobemide Comments: TAB (100, 150 mg) ORAL Date: 92-08-12 ----------------------------------------------------------------- Brand Name: Maxaquin Source: Searle Active Ingredient: Lomefloxacin hydrochloride Comments: TAB (400 mg) ORL Date: 92-10-27 ----------------------------------------------------------------- Brand Name: Meclomen Source: Parke Davis Active Ingredient: Meclofenamate sodium Comments: CAP (50, 100 mg) ORL Date: 92-11-20 ----------------------------------------------------------------- Brand Name: Mefoxin Source: Merck Sharp & Dohme Active Ingredient: Cefoxitin sodium Comments: Change in packaging Date: 92-02-05 ----------------------------------------------------------------- Brand Name: Mefoxin Source: Merck Sharp & Dohme Active Ingredient: Cefoxitin sodium Comments: New strength Date: 92-04-03 ----------------------------------------------------------------- Brand Name: Megace Source: Bristol Labs Active Ingredient: Megestrol acetate Comments: New indication Date: 92-08-26 ----------------------------------------------------------------- Brand Name: Mepron Source: Burroughs Wellcome Active Ingredient: Atovaquone Comments: TAB (250 mg) ORL Date: 92-11-25 ----------------------------------------------------------------- Brand Name: Methylprednisolone Sodium Succinate Injection USP Source: Kenral Active Ingredient: Methylprednisolone Sodium Succinate Comments: PWS (40 mg) IM, IV Date: 92-01-24 ----------------------------------------------------------------- Brand Name: Methylprednisolone Sodium Succinate Injection USP Source: Kenral Active Ingredient: Methylprednisolone Sodium Succinate Comments: PWS (125 mg) IM, IV Date: 92-01-24 ----------------------------------------------------------------- Brand Name: Methylprednisolone Sodium Succinate Injection USP Source: Kenral Active Ingredient: Methylprednisolone Sodium Succinate Comments: PWS (1000 mg) IM, IV Date: 92-01-24 ----------------------------------------------------------------- Brand Name: Methylprednisolone Sodium Succinate Injection USP Source: Kenral Active Ingredient: Methylprednisolone Sodium Succinate Comments: PWS (500 mg) IM, IV Date: 92-01-24 ----------------------------------------------------------------- Brand Name: Metoclopramide Hydrochloride Source: David Bull Laboratories Active Ingredient: Metoclopramide hydrochloride Comments: Liq (5 mg/mL) IV Date: 92-03-26 ----------------------------------------------------------------- Brand Name: Mevacor Source: Merck Sharp & Dohme Active Ingredient: Lovastatin Comments: New packaging Date: 92-05-14 ----------------------------------------------------------------- Brand Name: Mexitil Source: Boehringer Ingleheim Active Ingredient: Mexiletine hydrochloride Comments: Revised product monograph Date: 92-01-15 ----------------------------------------------------------------- Brand Name: Miacalcin Source: Sandoz Active Ingredient: Salcatonin Comments: LIQ (50, 100 IU/mL) IM, SC, IV Date: 92-07-13 ----------------------------------------------------------------- Brand Name: Micro I Source: Sabex Active Ingredient: Sodium iodide Comments: Change in product name, revised product monograph Date: 92-02-27 ----------------------------------------------------------------- Brand Name: Micro Se Injection Source: Sabex Active Ingredient: Selenious acid Comments: LIQ (40 mcg/mL [as Selenium]) IV Date: 92-05-27 ----------------------------------------------------------------- Brand Name: Midamor Source: Merck Sharp & Dohme Active Ingredient: Amiloride hydrochloride Comments: Revised product monograph Date: 92-11-17 ----------------------------------------------------------------- Brand Name: Minoxidil Topical Solution 2% Source: Kenral Active Ingredient: Minoxidil Comments: Revised product monograph Date: 92-02-19 ----------------------------------------------------------------- Brand Name: Modecate Concentrate Source: Bristol-Myers Squibb Active Ingredient: Fluphenazine decanoate Comments: New source of finished product Date: 92-10-23 ----------------------------------------------------------------- Brand Name: Monocid Source: SmithKline Active Ingredient: Cefonicid sodium Comments: PWS (500 mg & 1g/vial) IM, IV Date: 92-02-17 ----------------------------------------------------------------- Brand Name: Monopril Source: Bristol-Myers Squibb Active Ingredient: Fosinopril sodium Comments: Tab (5, 10, 20 mg) Oral Date: 92-04-09 ----------------------------------------------------------------- Brand Name: MTE-4 and MTE-4 Concentrated Source: Lyphomed Active Ingredient: Zinc sulfate, copper sulfate, manganese sulfate, chromium chloride Comments: Alternate manufacturing site Date: 92-06-19 ----------------------------------------------------------------- Brand Name: Mycostatin Vaginal Cream Source: Bristol-Myers Squibb Active Ingredient: Nystatin Comments: Change in manufacturing, alternate manufacturing site Date: 92-08-12 ----------------------------------------------------------------- Brand Name: Naprosyn E Source: Syntex Active Ingredient: Naproxen Comments: New dosage form Date: 92-08-06 ----------------------------------------------------------------- Brand Name: Narcan Source: Dupont Merck Pharma Active Ingredient: Naloxone Hydrochloride Comments: Change in manufacturer's name, new packaging Date: 92-07-27 ----------------------------------------------------------------- Brand Name: Nasacort Source: Rhone-Poulenc Rorer Active Ingredient: Triamcinolone acetonide Comments: AER (100 mcg/metered dose) INH Date: 92-05-05 ----------------------------------------------------------------- Brand Name: Neggram Source: Sterling-Winthrop Active Ingredient: Nalidixic acid Comments: Revised product monograph Date: 92-01-30 ----------------------------------------------------------------- Brand Name: Neodecadron Source: Merck Sharp and Dohme Active Ingredient: Dexamethasone sodium phosphate/neomycin sulfate Comments: Change in manufacturing Date: 92-03-11 ----------------------------------------------------------------- Brand Name: Nicoderm Source: Merrell Dow Active Ingredient: Nicotine Comments: Patch (7, 14, 21 mg/day) TRD Date: 92-05-12 ----------------------------------------------------------------- Brand Name: Nimotop I.V. Source: Miles Active Ingredient: Nimodipine Comments: New dosage form Date: 92-07-09 ----------------------------------------------------------------- Brand Name: Nipent Source: Parke Davis Active Ingredient: Pentostatin Comments: PWS (10 mg/vial) IV Date: 92-11-06 ----------------------------------------------------------------- Brand Name: Nitro-Dur 0.8 Source: Key Pharmaceuticals Active Ingredient: Nitroglycerin Comments: New strength Date: 92-11-09 ----------------------------------------------------------------- Brand Name: Nizoral Source: Janssen Active Ingredient: Ketoconazole Comments: New indication Date: 92-09-24 ----------------------------------------------------------------- Brand Name: Norcuron Source: Organon Active Ingredient: Vecuronium bromide Comments: New source of finished product Date: 92-11-17 ----------------------------------------------------------------- Brand Name: Noroxin Source: Merck Sharp and Dohme Active Ingredient: Norfloxacin Comments: Revised product monograph Date: 92-10-02 ----------------------------------------------------------------- Brand Name: Norpace & Norpace CR Source: Searle Active Ingredient: Disopyramide phosphate Comments: Revised product monograph Date: 92-03-09 ----------------------------------------------------------------- Brand Name: Norvasc Source: Pfizer Active Ingredient: Amlodipine besylate Comments: TAB (5, 10 mg) ORL Date: 92-06-26 ----------------------------------------------------------------- Brand Name: Novamilor Tablets Source: Novopharm Active Ingredient: Amiloride Hydrochloride, Hydrochlorothiazide Comments: Tab (5/50 mg) Oral Date: 92-02-07 ----------------------------------------------------------------- Brand Name: Novantrone Source: Lederle - Cyanamid Active Ingredient: Mitoxantrone hydrochloride Comments: New expiration date, change in packaging Date: 92-04-01 ----------------------------------------------------------------- Brand Name: Novo-Atenol Source: Novopharm Active Ingredient: Atenolol Comments: Alternate source of active ingredient Date: 92-04-29 ----------------------------------------------------------------- Brand Name: Novo-AZT Source: Novopharm Active Ingredient: Zidovudine Comments: CAP (100 mg) ORAL Date: 92-07-20 ----------------------------------------------------------------- Brand Name: Novo-Dipiradol Source: Novopharm Active Ingredient: Dipyridamole Comments: New packaging Date: 92-05-27 ----------------------------------------------------------------- Brand Name: Novo-Doxepin Source: Novopharm Active Ingredient: Doxepin Hydrochloride Comments: Cap (75 mg) Oral Date: 92-04-08 ----------------------------------------------------------------- Brand Name: Novo-Doxepin Source: Novopharm Active Ingredient: Doxepin Hydrochloride Comments: Cap (100 mg) Oral Date: 92-04-08 ----------------------------------------------------------------- Brand Name: Novo-Doxepin Source: Novopharm Active Ingredient: Doxepin Hydrochloride Comments: Cap (150 mg) Oral Date: 92-04-08 ----------------------------------------------------------------- Brand Name: Novo-Doxepin Source: Novopharm Active Ingredient: Doxepin Hydrochloride Comments: Cap (50 mg) Oral Date: 92-04-08 ----------------------------------------------------------------- Brand Name: Novo-Doxepin Source: Novopharm Active Ingredient: Doxepin Hydrochloride Comments: Cap (25 mg) Oral Date: 92-04-08 ----------------------------------------------------------------- Brand Name: Novo-Doxylin Source: Novopharm Active Ingredient: Doxycycline hyclate Comments: New packaging Date: 92-11-17 ----------------------------------------------------------------- Brand Name: Novo-Hylazin Source: Novopharm Active Ingredient: Hydralazine hydrochloride Comments: New strength Date: 92-05-14 ----------------------------------------------------------------- Brand Name: Novo-Keto-EC Source: Novopharm Active Ingredient: Ketoprofen Comments: TAB (50, 100 mg) ORL Date: 92-06-26 ----------------------------------------------------------------- Brand Name: Novo-Nifedin Source: Novopharm Active Ingredient: Nifedipine Comments: Alternate source of active ingredient Date: 92-05-01 ----------------------------------------------------------------- Brand Name: Novo-Timol Source: Novopharm Active Ingredient: Timolol Maleate Comments: TAB (5, 10, 20 mg) ORAL Date: 92-06-01 ----------------------------------------------------------------- Brand Name: Novo-Triolam Source: Novopharm Active Ingredient: Triazolam Comments: Revised product monograph Date: 92-03-19 ----------------------------------------------------------------- Brand Name: Nu-Capto Source: Nu-Pharm Active Ingredient: Captopril Comments: Revised product monograph Date: 92-08-28 ----------------------------------------------------------------- Brand Name: Nu-Hydral Source: Nu-Pharm Active Ingredient: Hydralazine hydrochloride Comments: New strengths Date: 92-09-11 ----------------------------------------------------------------- Brand Name: Nu-Triazo Source: Nu-Pharm Active Ingredient: Triazolam Comments: Revised product monograph Date: 92-03-19 ----------------------------------------------------------------- Brand Name: Nu-Triazo Source: Nu-Pharm Active Ingredient: Triazolam Comments: New packaging Date: 92-07-24 ----------------------------------------------------------------- Brand Name: Nuromax Source: Burroughs Wellcome Active Ingredient: Doxacurium chloride Comments: Liq (1 mg/mL as Doxacurium) IV Date: 92-04-15 ----------------------------------------------------------------- Brand Name: Ofloxacin Source: Ortho-McNeil Active Ingredient: Ofloxacin Comments: Revised product monograph Date: 92-07-29 ----------------------------------------------------------------- Brand Name: Omnipaque Source: Sterling-Winthrop Active Ingredient: Iohexol Comments: New packaging Date: 92-04-27 ----------------------------------------------------------------- Brand Name: Omnipaque Source: Sterling-Winthrop Active Ingredient: Iohexol Comments: Change in packaging Date: 92-08-13 ----------------------------------------------------------------- Brand Name: Omnipaque Source: Sterling-Winthrop Active Ingredient: Iohexol Comments: New packaging Date: 92-12-23 ----------------------------------------------------------------- Brand Name: Omnipaque 300 Source: Sterling-Winthrop Active Ingredient: Iohexol Comments: New packaging Date: 92-06-26 ----------------------------------------------------------------- Brand Name: One-Alpha Source: Leo Laboratories Active Ingredient: Alfacalcidol Comments: Change in packaging Date: 92-11-17 ----------------------------------------------------------------- Brand Name: Orafen Source: Pharmascience Active Ingredient: Ibuprofen Comments: TAB (200 mg) ORL Date: 92-09-29 ----------------------------------------------------------------- Brand Name: Oramorph SR Source: Roxane Labs Active Ingredient: Morphine sulfate Comments: TAB (30, 60, 100 mg) ORAL Date: 92-06-04 ----------------------------------------------------------------- Brand Name: Ostac Source: Boehringer Mannheim Active Ingredient: Clodronate disodium Comments: CAP (400 mg) ORAL, LIQ (30 mg/mL) IV Date: 92-08-27 ----------------------------------------------------------------- Brand Name: Parlodel Source: Sandoz Active Ingredient: Bromocriptine mesylate Comments: Change in manufacturing Date: 92-08-10 ----------------------------------------------------------------- Brand Name: Parlodel Source: Sandoz Active Ingredient: Bromocriptine mesylate Comments: New indication Date: 92-10-09 ----------------------------------------------------------------- Brand Name: Penetrex Source: Rhone-Poulenc Rorer Active Ingredient: Enoxacin Comments: TAB (200, 400 mg) ORL Date: 92-10-20 ----------------------------------------------------------------- Brand Name: Pentaspan Source: Du Pont Merck Pharma Active Ingredient: Pentastarch/Sodium Chloride Comments: LIQ (10%/0.9%) IV Date: 92-02-27 ----------------------------------------------------------------- Brand Name: Pepcid Source: Merck Sharp & Dohme Active Ingredient: Famotidine Comments: New packaging, revised product monograph Date: 92-06-11 ----------------------------------------------------------------- Brand Name: Pharmorubicin PFS Source: Adria Active Ingredient: Epirubicin hydrochloride Comments: New dosage form Date: 92-03-11 ----------------------------------------------------------------- Brand Name: PMS - Ketoprofen Source: Pharmascience Active Ingredient: Ketoprofen Comments: SUP (100 mg) RT Date: 92-12-22 ----------------------------------------------------------------- Brand Name: PMS - Sodium Cromoglycate Nasal Solution Source: Pharmascience Active Ingredient: Cromolyn sodium Comments: LIQ (2 %) NAS Date: 92-11-17 ----------------------------------------------------------------- Brand Name: PMS-Amantadine HCL CAP 100 mg Source: Pharmascience Active Ingredient: Amantadine hydrochloride Comments: CAP (100 mg) ORL Date: 92-06-25 ----------------------------------------------------------------- Brand Name: PMS-Diazepam Oral Soultion Source: Pharmascience Active Ingredient: Diazepam Comments: New dosage form Date: 92-06-19 ----------------------------------------------------------------- Brand Name: PMS-Isosorbide Source: Pharmascience Active Ingredient: Isosorbide dinitrate Comments: Change in formulation, new expiration date Date: 92-08-12 ----------------------------------------------------------------- Brand Name: PMS-Sodium Cromoglycate Opthalmic Solution Source: Pharmascience Active Ingredient: Sodium cromoglycate Comments: LIQ (2 %) OPH Date: 92-10-23 ----------------------------------------------------------------- Brand Name: PMS-Trazodone Source: Pharmascience Active Ingredient: Trazodone hydrochloride Comments: TAB (50, 100 mg) ORL Date: 92-12-04 ----------------------------------------------------------------- Brand Name: Polytrim Ophthalmic Solution Source: Allergan Active Ingredient: Trimethoprim sulfate / Polymyxin B sulfate Comments: LIQ (1.0 mg / 10,000 UNIT) OPH Date: 92-11-19 ----------------------------------------------------------------- Brand Name: Prepulsid Source: Janssen Active Ingredient: Cisapride Comments: New indication, new dosage regimen Date: 92-03-09 ----------------------------------------------------------------- Brand Name: Primacor Source: Sanofi Winthrop Active Ingredient: Milrinone lactate Comments: LIQ (1 mg/mL base) IV Date: 92-09-10 ----------------------------------------------------------------- Brand Name: Primaxin IV Source: Merck Sharp & Dohme Active Ingredient: Imipenem and cilastatin sodium Comments: Change in packaging Date: 92-02-05 ----------------------------------------------------------------- Brand Name: Prinivil Tablets Source: Merck Sharp & Dohme Active Ingredient: Lisinopril Comments: Revised product monograph Date: 92-08-28 ----------------------------------------------------------------- Brand Name: Prinzide Source: Merck Sharp & Dohme Active Ingredient: Lisinopril / Hydrochlorothiazide Comments: TAB (20 / 12.5, 20 / 25 mg) ORL Date: 92-10-29 ----------------------------------------------------------------- Brand Name: Procainamide Hydrochloride Source: Laboratoires Pro-Doc Active Ingredient: Procainamide hydrochloride Comments: Revised product monograph Date: 92-01-29 ----------------------------------------------------------------- Brand Name: Procalamine Source: McGaw Active Ingredient: Amino acid, glycerin and electorlytes Comments: Change in manufacturing Date: 92-08-31 ----------------------------------------------------------------- Brand Name: Procan SR Source: Parke-Davis Active Ingredient: Procainamide hydrochloride Comments: Revised product monograph Date: 92-02-05 ----------------------------------------------------------------- Brand Name: Prohance Source: Squibb Active Ingredient: Gadoteridol Comments: LIQ (279.3 mg/mL) IV Date: 92-12-23 ----------------------------------------------------------------- Brand Name: Proloprim Source: Burroughs Wellcome Active Ingredient: Trimethoprim Comments: New expiration date Date: 92-04-09 ----------------------------------------------------------------- Brand Name: Pronestyl, Pronestyl SR Source: Squibb Canada Active Ingredient: Procainamide hydrochloride Comments: Revised product monograph Date: 92-08-04 ----------------------------------------------------------------- Brand Name: Propine Source: Allergan Active Ingredient: Dipiverfrin hydrochloride Comments: Change in formulation Date: 92-01-30 ----------------------------------------------------------------- Brand Name: Proscar Source: Merck Sharp & Dohme Active Ingredient: Finasteride Comments: TAB (5 mg) ORL Date: 92-10-23 ----------------------------------------------------------------- Brand Name: Prosom Source: Abbott Active Ingredient: Estazolam Comments: TAB (1, 2 mg) ORL Date: 92-12-29 ----------------------------------------------------------------- Brand Name: Prozac Source: Eli Lilly Active Ingredient: Fluoxetine hydrochloride Comments: New indication Date: 92-09-04 ----------------------------------------------------------------- Brand Name: Pulmicort Nebuamp Source: Astra Pharma Active Ingredient: Budesonide Comments: New dosage form Date: 92-03-13 ----------------------------------------------------------------- Brand Name: Quinaglute Dura-Tabs Source: Berlex Active Ingredient: Quinidine gluconate Comments: Revised product monograph Date: 92-05-25 ----------------------------------------------------------------- Brand Name: Quinidine Gluconate Source: Eli Lilly Active Ingredient: Quinidine Gluconate Comments: New indication Date: 92-02-25 ----------------------------------------------------------------- Brand Name: Renedil Source: Hoechst-Roussel Active Ingredient: Felodipine Comments: SRT (5, 10 mg) ORL Date: 92-06-18 ----------------------------------------------------------------- Brand Name: Restoril Source: Sandoz Active Ingredient: Temazepam Comments: New packaging Date: 92-01-22 ----------------------------------------------------------------- Brand Name: Retisol-A Source: Stiefel Active Ingredient: Tretinoin Comments: CRM (0.01, 0.025, 0.05, 0.1 %) TOP Date: 92-10-01 ----------------------------------------------------------------- Brand Name: Rev-Eyes Source: Angelini Active Ingredient: Dapiprazole hydrochloride Comments: PWS (25 mg/vial) Oph Date: 92-03-17 ----------------------------------------------------------------- Brand Name: Rhinaris-F Source: Pharmascience Active Ingredient: Flunisolide Comments: ASP (0.025 %) NAS Date: 92-10-29 ----------------------------------------------------------------- Brand Name: Rhinocort Aqua Source: Astra Pharma Active Ingredient: Budesonide Comments: New dosage form Date: 92-09-02 ----------------------------------------------------------------- Brand Name: Rhovane Source: Rhodiapharm Active Ingredient: Zopiclone Comments: TAB (7.5 mg) ORL Date: 92-09-29 ----------------------------------------------------------------- Brand Name: Rhythmodan Source: Roussel Active Ingredient: Disopyramide phosphate Comments: Revised product monograph Date: 92-02-12 ----------------------------------------------------------------- Brand Name: Rhythmodan Source: Hoechst-Roussel Active Ingredient: Disopyramide phosphate Comments: Change in formulation Date: 92-06-18 ----------------------------------------------------------------- Brand Name: Rhythmodan Injection Source: Hoechst-Roussel Active Ingredient: Disopyramide phosphate Comments: Change in formulation Date: 92-06-18 ----------------------------------------------------------------- Brand Name: Rocephin Source: Hoffmann-La Roche Active Ingredient: Ceftriaxone disodium Comments: Revised product monograph Date: 92-08-26 ----------------------------------------------------------------- Brand Name: Salazopyrin Oral Suspension Source: Kabi-Pharmacia Active Ingredient: Sulfasalazine Comments: SUS (50 mg/mL) ORL Date: 92-09-11 ----------------------------------------------------------------- Brand Name: Salbutamol Sulphate Respirator Solution Unit Dose P.F. Source: Kenral Active Ingredient: Salbutamol Comments: Change of manufacturer Date: 92-05-28 ----------------------------------------------------------------- Brand Name: Sandimmune Source: Sandoz Active Ingredient: Cyclosporine Comments: New expiration date Date: 92-02-27 ----------------------------------------------------------------- Brand Name: Sandimmune Source: Sandoz Active Ingredient: Cyclosporine Comments: New indication, revised product monograph Date: 92-10-09 ----------------------------------------------------------------- Brand Name: Selexid Source: Leo Laboratories Active Ingredient: Pivmecillinam hydrochloride Comments: New packaging Date: 92-02-20 ----------------------------------------------------------------- Brand Name: Sensorcaine Source: Astra Pharma Active Ingredient: Bupivacaine hydrochloride Comments: LIQ (0.25, 0.375, 0.5 %) BiN - EPD Date: 92-09-04 ----------------------------------------------------------------- Brand Name: Sensorcaine Forte Source: Astra Pharma Active Ingredient: Bupivacaine hydrochloride / epinephrine bitartrate Comments: LIQ (5 mg / 5 mcg per mL) BiN Date: 92-09-04 ----------------------------------------------------------------- Brand Name: Sensorcaine with Epinephrine Source: Astra Pharma Active Ingredient: Bupivacaine hydrochloride / epinephirne bitartrate Comments: LIQ (2.5 mg / 5 mcg per mL, 3.75 mg / 5 mcg per mL, 5 mg / 5 mcg per mL) BiN - EPD Date: 92-09-04 ----------------------------------------------------------------- Brand Name: Stievamycin Forte Source: Stiefel Active Ingredient: Tretinoine/erythromycin Comments: New strength Date: 92-05-21 ----------------------------------------------------------------- Brand Name: Stievamycin Mild Source: Stiefel Active Ingredient: Tretinoin / Erythromycin Comments: New strength Date: 92-12-23 ----------------------------------------------------------------- Brand Name: Sulcrate Suspension Source: Nordic Active Ingredient: Sucralfate Comments: New indication Date: 92-07-20 ----------------------------------------------------------------- Brand Name: Suprax Source: Lederle Active Ingredient: Cefixime Comments: Change in manufacturing, change in manufacturing site Date: 92-12-17 ----------------------------------------------------------------- Brand Name: Suprefact Source: Hoechst-Roussel Active Ingredient: Buserelin acetate Comments: Change in formulation Date: 92-08-06 ----------------------------------------------------------------- Brand Name: Suprefact Injection Source: Hoechst-Roussel Active Ingredient: Buserelin acetate Comments: LIQ (1 mg/mL) SC Date: 92-06-18 ----------------------------------------------------------------- Brand Name: Suprefact Solution Source: Hoechst-Roussel Active Ingredient: Buserelin acetate Comments: SOL (1 mg/mL) NASAL Date: 92-06-18 ----------------------------------------------------------------- Brand Name: Surgam Source: Hoechst-Roussel Active Ingredient: Tiaprofenic acid Comments: TAB (200, 300 mg) ORL, SRC (300 mg) ORL Date: 92-06-25 ----------------------------------------------------------------- Brand Name: Synamol Source: Syntex Active Ingredient: Flucinolone acetonide Comments: Change in manufacturing Date: 92-11-17 ----------------------------------------------------------------- Brand Name: Synflex/Synflex DS Source: Syncare Active Ingredient: Naproxen sodium Comments: Change in manufacturing Date: 92-07-09 ----------------------------------------------------------------- Brand Name: Tagamet Source: SmithKline Active Ingredient: Cimetidine Comments: New indication Date: 92-03-02 ----------------------------------------------------------------- Brand Name: Talidan Source: Dista Products Active Ingredient: Fluoxetine Hydrochloride Comments: Cap (20 mg) Orl Date: 92-02-12 ----------------------------------------------------------------- Brand Name: Talidan Source: Dista Products Active Ingredient: Fluoxetine Hydrochloride Comments: Cap (10 mg) Orl Date: 92-02-12 ----------------------------------------------------------------- Brand Name: Tambocor Source: Riker Active Ingredient: Flecainide acetate Comments: Revised product monograph Date: 92-02-12 ----------------------------------------------------------------- Brand Name: Tambocor Source: 3M Pharmaceuticals Active Ingredient: Flecainide acetate Comments: New indication Date: 92-07-03 ----------------------------------------------------------------- Brand Name: Tambocor Source: 3M Pharmaceuticals Active Ingredient: Flecainide acetate Comments: Change in manufacturer's name Date: 92-07-09 ----------------------------------------------------------------- Brand Name: Tambocor Source: 3M Pharmaceutical Active Ingredient: Flecainide acetate Comments: New packaging Date: 92-11-17 ----------------------------------------------------------------- Brand Name: Tamotec Source: Technilab Active Ingredient: Tamoxifen citrate Comments: TAB (10, 20 mg) ORL Date: 92-04-29 ----------------------------------------------------------------- Brand Name: Taxol Source: Bristol-Myers Squibb Active Ingredient: Paclitaxel Comments: LIQ (6 mg/mL) IV Date: 92-12-29 ----------------------------------------------------------------- Brand Name: Tazidime Source: Eli Lilly Active Ingredient: Ceftazidime pentahydrate Comments: Change in manufacturing Date: 92-04-01 ----------------------------------------------------------------- Brand Name: Tegretol Source: Geigy Active Ingredient: Carbamazepine Comments: New indication Date: 92-08-25 ----------------------------------------------------------------- Brand Name: Terazol 3, 7 Vaginal Cream Source: Ortho-McNeil Active Ingredient: Terconazole Comments: Change in manufacturing Date: 92-12-07 ----------------------------------------------------------------- Brand Name: Theo-Dur Slow Release Tablets Source: Astra Pharma Active Ingredient: Theophylline Comments: New expiration date Date: 92-01-29 ----------------------------------------------------------------- Brand Name: Thiotepa for injection Source: Lederle - Cyanamid Active Ingredient: Thiotepa Comments: Change in formulation Date: 92-03-30 ----------------------------------------------------------------- Brand Name: Tim-Ak Source: Akorn Active Ingredient: Timolol maleate Comments: LIQ (.5, .25 %) OPH Date: 92-10-19 ----------------------------------------------------------------- Brand Name: Timpilo Source: Merck Sharpe & Dohme Active Ingredient: Timolol maleate/pilocarpine hydrochloride Comments: Sol (0.5%/2%, 0.5%/4%) Ophthalmic Date: 92-01-24 ----------------------------------------------------------------- Brand Name: Topicort Source: Hoechst Active Ingredient: Desoximetasone Comments: New dosage form Date: 92-05-21 ----------------------------------------------------------------- Brand Name: Topicort Ointment Source: Hoechst-Roussel Active Ingredient: Desoximetasone Comments: ONT (0.25 %) TOP Date: 92-07-09 ----------------------------------------------------------------- Brand Name: Toradol I.M. Source: Syntex Active Ingredient: Ketorolac tromethamine Comments: New packaging Date: 92-06-08 ----------------------------------------------------------------- Brand Name: Transderm-Nitro Source: Ciba Active Ingredient: Nitroglycerin Comments: Alternate source of active ingredient, alternate manufacturing site Date: 92-03-25 ----------------------------------------------------------------- Brand Name: Travasol Amino Acid Source: Clintec Active Ingredient: Amino acid / Dextrose Comments: LIQ (2.5 / 10, 4.25 / 5, 4.25 / 10, 4.25 / 20, 4.25 / 25, 5 / 5, 5 / 10, 5 / 20, 5 / 25 %) IV Date: 92-12-23 ----------------------------------------------------------------- Brand Name: Travasol Amino Acid Source: Clintec Active Ingredient: Amino acid / Electrolytes / Dextrose Comments: LIQ (2.5 / 10, 2.5 / 25, 2.75 / 5, 2.75 / 5, 2.75 / 25, 4.25 / 5, 4.25 / 10, 4.25 / 20, 4.25 / 25, 5 / 10, 5 / 16.6, 5 / 20, 5 / 25 %) IV Date: 92-12-23 ----------------------------------------------------------------- Brand Name: Trental Source: Hoechst-Roussel Active Ingredient: Pentoxifylline Comments: Change in formulation Date: 92-06-18 ----------------------------------------------------------------- Brand Name: Triadox Source: Labs Trianon Active Ingredient: Doxycycline hydrochloride Comments: CAP (100 mg) ORL Date: 92-03-16 ----------------------------------------------------------------- Brand Name: Triadox Source: Labs Trianon Active Ingredient: Doxycycline hydrochloride Comments: New dosage form Date: 92-03-16 ----------------------------------------------------------------- Brand Name: Triazolam Source: Kenral Active Ingredient: Triazolam Comments: Revised product monograph Date: 92-03-19 ----------------------------------------------------------------- Brand Name: Triazolam-Ak Source: Akorn Active Ingredient: Triazolam Comments: TAB (0.25, 0.125 mg) ORL Date: 92-10-19 ----------------------------------------------------------------- Brand Name: Tribrissen 120 Tablets Source: Janssen Active Ingredient: Trimethoprim/Sulfadiazine Comments: TAB (20/100 mg) ORL Date: 92-05-21 ----------------------------------------------------------------- Brand Name: Tribrissen 24% Injection Source: Janssen Active Ingredient: Trimethoprim/Sulfadiazine Comments: LIQ (40/200 mg) IV Date: 92-05-21 ----------------------------------------------------------------- Brand Name: Tribrissen 30 Tablets Source: Janssen Active Ingredient: Trimethoprim/Sulfadiazine Comments: TAB (5/25 mg) ORL Date: 92-05-21 ----------------------------------------------------------------- Brand Name: Tribrissen 48% Injection Source: Janssen Active Ingredient: Trimethoprim/Sulfadiazine Comments: LIQ (80/400 mg) IV Date: 92-05-21 ----------------------------------------------------------------- Brand Name: Tribrissen 480 Tablets Source: Janssen Active Ingredient: Trimethoprim/Sulfadiazine Comments: TAB (80/400 mg) ORL Date: 92-05-21 ----------------------------------------------------------------- Brand Name: Tribrissen Oral Paste Source: Janssen Active Ingredient: Trimethoprim/Sulfadiazine Comments: PASTE (0.25/1.25 gm) ORL Date: 92-05-21 ----------------------------------------------------------------- Brand Name: Triptil Source: Merck Sharp and Dohme Active Ingredient: Protriptyline hydrochloride Comments: Change in formulation Date: 92-03-11 ----------------------------------------------------------------- Brand Name: Uniphyl Source: Purdue Active Ingredient: Theophylline Comments: New expiration date Date: 92-12-29 ----------------------------------------------------------------- Brand Name: Urocit-K Source: Mission Pharmacal Active Ingredient: Potassium citrate Comments: SRT (540 mg) ORAL Date: 92-08-20 ----------------------------------------------------------------- Brand Name: Vamin N Source: Kabi Active Ingredient: Amino acids / Electrolytes Comments: LIQ (7 %) IV Date: 92-09-21 ----------------------------------------------------------------- Brand Name: Vancocin Source: Eli Lilly Active Ingredient: Vancomycin hydrochloride Comments: Revised specification Date: 92-04-01 ----------------------------------------------------------------- Brand Name: Vancocin Source: Eli Lilly Active Ingredient: Vancomycin hydrochloride Comments: New strength Date: 92-12-17 ----------------------------------------------------------------- Brand Name: Vancomycin Hydrochloride Sterile Source: Lyphomed Active Ingredient: Vancomycin hydrochloride Comments: Change in manufacturing Date: 92-09-04 ----------------------------------------------------------------- Brand Name: Vancomycin Hydrochloride, U.S.P., Sterile Source: Lyphomed Active Ingredient: Vancomycin Hydrochloride Comments: PWS (0.5, 1.0, 5.0 g/vial) I.V. Date: 92-07-06 ----------------------------------------------------------------- Brand Name: Vaseretic Tablets Source: Frosst Active Ingredient: Enalapril maleate / hydrochlorothiazide Comments: Revised product monograph Date: 92-08-28 ----------------------------------------------------------------- Brand Name: Vasotec I.V. Source: Frosst Active Ingredient: Enalaprilat Comments: Revised product monograph Date: 92-08-28 ----------------------------------------------------------------- Brand Name: Vasotec Tablets Source: Frosst Active Ingredient: Enalapril maleate Comments: Revised products monograph Date: 92-08-28 ----------------------------------------------------------------- Brand Name: Ventodisk Source: Glaxo Active Ingredient: Salbutamol sulphate Comments: New expiration date Date: 92-02-24 ----------------------------------------------------------------- Brand Name: Versed Source: Hoffmann-La Roche Active Ingredient: Midazolam hydrochloride Comments: New expiration date Date: 92-08-13 ----------------------------------------------------------------- Brand Name: Versed Source: Hoffmann-La Roche Active Ingredient: Midazolam hydrochloride Comments: Revised product monograph Date: 92-09-16 ----------------------------------------------------------------- Brand Name: Vinblastine Sulfate injection Source: David Bull Active Ingredient: Vinblastine sulfate Comments: New dosage form Date: 92-03-13 ----------------------------------------------------------------- Brand Name: Vincasar PFS Source: Adria Labs Active Ingredient: Vincristine sulfate Comments: LIQ (1 mg/mL) IV Date: 92-11-06 ----------------------------------------------------------------- Brand Name: Vincristine Sulfate Source: Lyphomed Active Ingredient: Vincristine sulfate Comments: New packaging Date: 92-07-29 ----------------------------------------------------------------- Brand Name: Vincristine Sulphate Source: David Bull Active Ingredient: Vincristine sulphate Comments: New packaging, new specifications Date: 92-07-13 ----------------------------------------------------------------- Brand Name: Virostat Source: McNeil Active Ingredient: Edoxudine Comments: CRM (3 %) TOP Date: 92-09-22 ----------------------------------------------------------------- Brand Name: Xanax, Xanax TS Source: UpJohn Active Ingredient: Alprazolam Comments: New strength, new indication Date: 92-12-07 ----------------------------------------------------------------- Brand Name: Zaditen Source: Sandoz Active Ingredient: Ketotifen fumarate Comments: New expiration date Date: 92-02-24 ----------------------------------------------------------------- Brand Name: Zantac Source: Glaxo Active Ingredient: Ranitidine hydrochloride Comments: New expiration date Date: 92-02-27 ----------------------------------------------------------------- Brand Name: Zantac Tablets & Oral Solution, Zantac-C Capsules Source: Glaxo Active Ingredient: Ranitidine hydrochloride Comments: New indications Date: 92-05-25 ----------------------------------------------------------------- Brand Name: Zestoretic Source: I.C.I. Pharma Active Ingredient: Lisinopril / Hydrochlorothiazide Comments: TAB (20 / 12.5, 20 / 25 mg) ORL Date: 92-10-07 ----------------------------------------------------------------- Brand Name: Zestril Source: I.C.I. Pharma Active Ingredient: Lisinopril Comments: Change in manufacturing Date: 92-10-09 ----------------------------------------------------------------- Brand Name: Zestril Tablets Source: I.C.I. Pharma Active Ingredient: Lisinopril Comments: Revised product monograph Date: 92-07-13 ----------------------------------------------------------------- Brand Name: Zofran Source: Glaxo Active Ingredient: Ondansetron hydrochloride Comments: New indication, revised product monograph Date: 92-08-27 ----------------------------------------------------------------- Brand Name: Zoloft Source: Pfizer Active Ingredient: Sertraline hydrochloride Comments: Cap (50, 100, 150, 200 mg) Oral Date: 92-01-30 ----------------------------------------------------------------- Brand Name: Zoloft Source: Pfizer Active Ingredient: Sertraline hydrochloride Comments: Alternate source of active ingredient Date: 92-12-17 ----------------------------------------------------------------- Brand Name: Zovirax Source: Burroughs Wellcome Active Ingredient: Acyclovir Comments: New expiration date Date: 92-01-29 -----------------------------------------------------------------