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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

December August April
November July March
October June February
September May January

First-Time Generic Drug Approvals 2007

December August April
November July March
October June February
September May January

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.

Generic Drug Approvals 2000-2006
2006
Approvals First Generics Tentative Approvals
December December December
November November November
October October October
September September September
August August August
July July July
June June June
May May May
April April) April
March March March
February February February
January January January
2005
Approvals First Generics Tentative Approvals
December December December
November November November)
October October October
September September September
August August August
July July July
June June June
May May May
April April April
March March March
February February February
January January January
2004
Approvals First Generics Tentative Approvals
December December December
November November November
October October October
September September September
August August August
July July July
June June June
May May May
April April April
March March March
February February February
January January January
2003
Approvals First Generics Tentative Approvals
December December December
November November November
October October October
September September September
August August August
July July July
June June June
May May May
April April April
March March March
February February February
January January January
2002
Approvals First Generics Tentative Approvals
December December December
November November November
October October October
September September September
August August August
July July July
June June June
May May May
April April April
March March March
February February February
January January January
2001
Approvals First Generics Tentative Approvals
December December December
November November November
October October October
September September September
August August August
July July July
June June June
May May May
April April April
March March March
February February February
January January January
2000
Approvals First Generics Tentative Approvals
December December December
November November November
October October October
September September September
August August August
July July July
June June June
May May May

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Last updated: September 3, 2008

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