Drugs@FDA: FDA Approved Drug Products

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Drug Approval Reports by Month

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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. Does not include tentative approvals.

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

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Month: Year:

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