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Drug Approval Reports

1.  Select a Report:

What's in Each Report?
 All Approvals by Month
Approvals, tentative approvals, and supplements
Original New Drug Approvals (NDAs and BLAs) by Month
All applications approved for the first time during the selected month.
Includes New Molecular Entities (NMEs) and new biologics  * * Not all biologics are in Drugs@FDA.
Original Abbreviated New Drug Approvals (ANDAs) by Month
Generic Drug Approvals. Does not include tentative approvals
Supplements to New Drug Applications (NDAs and BLAs) by Month
Supplemental approvals to NDAs and BLAs
Tentative Approvals by Month
 

2.  Select a month and year  (mm/yyyy):          

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