Office of Generic Drugs (OGD)

General Information

http://www.fda.gov/cder/ogd/

For meeting request:

See Guidance for Industry: Formal Meetings with Sponsors and Applicants for PDUFA Products

Mailing Address

Office of Generic Drugs
Center for Drug Evaluation and Research
OGD Document Room
7500 Standish Place
Rockville, MD 20855

Document Room

Abbreviated New Drug Applications (ANDAs)
Office of Generic Drugs
7500 Standish Place
Rockville, MD 20855

Electronic Regulatory Submissions and Review

Questions as to whether your product is legally marketed

CDER's Office of Compliance
Division of New Drugs and Labeling Compliance
Phone: (301) 796-3100
Fax: (301) 847-8747