Drugs

Generic Drugs: Information for Industry

UPDATE:  The News and Announcements can now be found on the Office of Generic Drugs (OGD) page.   

Spotlight

Note: We highly recommend that firms consider submitting documents in electronic format.  The OGD document room has limited space and resources to maintain paper documents.

For paper submissions, postal carrier packages MUST be addressed to the document room (include “ATTN: DOCUMENT ROOM” in the address label) in order for the submission to be processed and tracked. Failure to do so will delay reviewer receipt and review of submission. Please send all submissions (original abbreviated new drug applications (ANDAs) ANDA amendments, ANDA supplements, ANDA resubmissions, and controlled correspondence) to the OGD document room address below:

Office of Generic Drugs
Center for Drug Evaluation and Research
Food and Drug Administration
Metro Park North VII
7620 Standish Place
Rockville, MD 20855
Hours of Operation:
Monday thru Friday 7:00AM - 6:00PM 
 
Your submission must include the application number. If you are sending a controlled correspondence, you must include “Controlled Correspondence” in the subject line of the cover letter. 
 
For the submission of Form FDA 3500A reports (15-day Alert Reports and Periodic Adverse Drug Experience Reports) to ANDAs, continue to send these to the following address:
 
Central Document Room
Center for Drug Evaluation and Research
5901-B Ammendale Road
Beltsville MD 20705-1266
Hours of Operation:
Monday thru Friday 7:00AM - 6:00PM 

Generic Drug Development Information

  • Guidances
  • The Office of Generic Drugs has revised the draft Question-based Review Chemistry questions (PDF - 107KB). The generics industry is encouraged to go through the revised draft questions and provide any feedback or suggestions.
  • Inactive Ingredient Database 
    The newly revised Inactive Ingredients Database provides information on inactive ingredients present in FDA-approved drug products. This information can be used by industry as an aid in developing drug products.
  • Bioequivalence Study Retention Samples (1/12/2001) 
    Regulations state that applicants shall retain reserve samples of the tested products administered to study subjects and release these samples to FDA upon request. The Agency may then analyze these retention samples to ensure that the BA/BE results upon which FDA bases approval of New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDAs) are reliable.
  • FDA Letters to Industry 
    This series of letters informs generic drug product manufacturers of policy and procedure developments with respect to the Drug Price Competition and Patent Term Restoration Act of 1984.

QbD

Quality by Design (QbD): An Example Pharmaceutical Development Report for an Immediate Release (IR) Dosage Form (PDF - 1.5MB)(5/2012) 

Abbreviated New Drug Application (ANDA) Submissions Information

Summary tables and additional ANDA submission resources previously found on this page can now be found on the ANDA Forms & Submission Requirements

Additional Resources 

Generic Drug Approvals

For first-time generics, see:
ANDA (Generic) Drug Approvals and
ANDA (Generic) Drug Approvals - Previous Years.

To find all Generic Approvals and Tentative Approvals, you can search Drugs@FDA, using the " Drug Approval Reports by Month" feature. We add new approvals and tentative approvals to Drugs@FDA Reports daily. 

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 

List of Authorized Generic Drugs

The quarterly List of Authorized Generic Drugs includes the drug trade name, the brand company manufacturer, and the date the authorized generic drug entered the market.

Generic Drug Petition Tracking

These petitions are submitted to FDA by drug companies seeking permission to file an abbreviated new drug application for a change from a listed drug in dosage form, strength, route of administration, or active ingredient in a combination product.   If FDA determines that the drug is suitable for a generic product, the petition is approved, if it is not suitable, the petition is denied.

 

Related Links

Contact FDA

240-402-7920
301-595-1147 Fax
Office of Generic Drugs

Immediate Office

10903 New Hampshire Avenue

Silver Spring, MD 20993

Page Last Updated: 11/05/2014
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