Drug authorizing
Learn about drug submission applications, the drug licensing process, drug identification numbers and notices of compliance.
Services and information
Drug licensing process
Learn about the drug review process and access related policy documents.
Guidance documents and forms for drug submissions
Access forms and guidance documents for preparing and filing a drug submission application.
Drug identification numbers
Find information on drug identification numbers, and guidance documents and forms to help you apply for one.
Notice of compliance for approved drugs
Browse notices of compliance issued to manufacturers once a drug is approved.
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