FDA List of Authorized Generic Drugs

Background Information

On September 27, 2007, the President signed into law the Food and Drug Administration Amendments Act (FDAAA) (Public Law 110-85).  Among other things, FDAAA added new subsection (t) to section 505 of the Federal Food, Drug, and Cosmetic Act (the Act).   Section 505(t) is titled “Database For Authorized Generic Drugs,” and requires that FDA publish a complete list on its Internet site of all authorized generic drugs, including (1) the drug trade name, (2) the brand company manufacturer, and (3) the date the authorized generic drug entered the market.  The agency is required to update the list quarterly.  Section 505(t)(2) of the Act requires the list to contain authorized generic drugs included in an annual report submitted to the agency after January 1, 1999.

What Is an Authorized Generic Drug?

An “authorized generic drug” is a listed drug as defined in § 314.3 that has been approved under subsection 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail class of trade with either labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark that differs from that of the listed drug.

How to Contact Us

You may e-mail questions about the List of Authorized Generics Drugs to:

Page Last Updated: 06/29/2016
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