General inquiries about drug products
Division of Drug Information
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993
Mailing Address for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs)
New Drug Applications (NDAs)
CDER Central Document Room:
FDA/Center for Drug Evaluation and Research (CDER)
Central Document Room (CDR)
5901-B Ammendale Road
Beltsville, MD 20705-1266
Abbreviated New Drug Applications (ANDAs)
Office of Generic Drugs (HFD-600)
Center for Drug Evaluation and Research
Food and Drug Administration
Central Document Room (CDR)
5901B Ammendale Road
Beltsville, MD 20705-1266
Mailing Address for Therapeutic Biologic License Applications (BLAs)
CDER Central Document Room:
FDA/Center for Drug Evaluation and Research (CDER)
Central Document Room (CDR)
5901-B Ammendale Road
Beltsville, MD 20705-1266
Mailing Addresses for Return of Adverse Event Reports to CDER
For voluntary reports from healthcare professionals and consumers:
MedWatch – Central Triage Unit
5600 Fishers Lane
Rockville, MD 20852-9787
For mandatory reports from regulated industry and IND reporters:
Central Document Room
Center for Drug Evaluation and Research
Food and Drug Administration
5901-B Ammendale Rd.
Beltsville, MD 20705-1266
Email Address
Phone Numbers:
- Main FDA for general inquiries: 1-888-INFO-FDA
(1-888-463-6332) - Drug Information: 301-796-3400 (8:00 a.m. – 4:30 p.m. Eastern Time)
- To submit a report about an Adverse Drug Reaction: MedWatch: 1-800-FDA-1088
Source: CDER