# Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs
> **Food and Drug Administration** · Final rule. · Published 2009-07-28 · Effective 2010-01-25 · 74 FR 37163
## Document
- **Document number:** E9-17963
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 74 FR 37163
- **CFR reference:** 21 CFR 314
- **Publication date:** 2009-07-28
- **Effective date:** 2010-01-25
- **HHS docket:** Docket No. FDA-2008-N-0341
## Abstract

The Food and Drug Administration (FDA) is amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report. We are taking this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2009/07/28/E9-17963/applications-for-food-and-drug-administration-approval-to-market-a-new-drug-postmarketing-reports)
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