Generic Drug Approvals
As of January 2007, we will update this page with monthly reports for First-Time Generics only.
To find all Generic Approvals and Tentative Approvals, you can search Drugs@FDA, using the "Drug Approval Reports by Month" feature. On the Drug Approval Reports page, select:
- "Original Abbreviated New Drug Approvals (ANDAs) by Month" for Generic Approvals
- "Tentative Approvals by Month" for Tentative Approvals
New approvals and tentative approvals are added to Drugs@FDA Reports on a daily basis, so you can run the reports every day to find the latest approvals.
First-Time Generic Drug Approvals 2008
First-Time Generic Drug Approvals 2007
Generic Drug Approvals 2000-2006
A tentative approval is issued to the applicant when the application is approvable prior to the expiration of any patents or exclusivities accorded to the reference listed drug product. A tentative approval does not allow the applicant to market the generic drug product and postpones the final approval until all patent/exclusivity issues have expired. First Generics are those drug products that have never been approved before as generic drug products and are new generic products to the marketplace.
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Last updated: September 3, 2008