Addresses to Send Applications
- Full drug marketing application submissions under 21 CFR subpart 314.50 and 314.54 should be directed to:
Center for Drug Evaluation and Research Food and Drug Administration Document and Records Section 5901-B Ammendale Rd Beltsville, Md. 20705-1266
- Abbreviated new drug applications under 21 CFR subpart 314.94, and amendments, supplements, and resubmissions; and
- Abbreviated antibiotic drug application submissions, as well as items sent by parcel post or overnight courier service to the Office of Generic Drugs, should be directed to:
| Office of Generic Drugs (HFD-600) |
| Center for Drug Evaluation and Research |
| Food and Drug Administration |
| Metro Park North II, Room 150 |
| 7500 Standish Place |
| Rockville, MD 20855 |
- Correspondence not associated with a particular application should be addressed specifically to the intended office or division and to the person as follows:
| Center for Drug Evaluation and Research |
| Food and Drug Administration |
| Attn: [insert name of person] |
| HFD-[insert mail code of office or division] |
| 5600 Fishers Lane |
Rockville, MD 20857 |