Complete response letters
FDA's letters telling drug and biologic applicants why an application was not approved as submitted. 458 records; openFDA updated it 2026-11-10. About this dataset
Newest records
- Approved309
- Unapproved149
- Fresenius Kabi USA, LLC · NDA 214610
U.S. FOOD & DRUG Sy ADMINISTRATION NDA 214610 COMPLETE RESPONSE Fresenius Kabi USA, LLC Attention: Jennifer Gross, M.S. Senior Regulatory Affairs Associate Three Corporate Drive Lake Zurich, IL 60047…
- Xspray Pharma AB · NDA 217644
yy U.S. FOOD & DRUG ADMINISTRATION NDA 217644 COMPLETE RESPONSE Xspray Pharma AB c/o Lachman Consultant Services, Inc. Attention: Jennifer Leaming Principal Consultant 1600 Stewart Avenue, Suite 604…
- Ipsen Biopharm Ltd. · BLA 761311
nN U.S. FOOD & DRUG ADMINISTRATION BLA 761311 COMPLETE RESPONSE Ipsen Biopharm Ltd. C/O Galderma Research and Development, Inc. Attention: Chase Edwards Director, Regulatory Affairs 2001 Ross Ave Sui…
- Elevar Therapeutics Inc. · NDA 216586
i Lk YN U.S. FOOD & DRUG ADMINISTRATION NDA 216586 COMPLETE RESPONSE Elevar Therapeutics Inc. ATTENTION: Young-Sil (Anna) Yim Executive Director, Regulatory Affairs: 1 Bridge Plaza North, Suite 850 F…
- Unicycive Therapeutics Inc. · NDA 218607
yy U.S. FOOD & DRUG ADMINISTRATION NDA 218607 COMPLETE RESPONSE Unicycive Therapeutics Inc. Attention: Shalabh Gupta, MD, MPA President & CEO 1975 W. El Camino Real, Suite 204 Mountain View, CA 94040…
- Corcept Therapeutics · NDA 219398
IN U.S. FOOD & DRUG ADMINISTRATION NDA 219398 CORRECTED COMPLETE RESPONSE Corcept Therapeutics Attention: Christopher Golis Vice President, Quality Assurance & Regulatory Affairs 101 Redwood Shores P…
- Jiangsu Hengrui Pharmaceuticals Co., Ltd. · BLA 761308
yy U.S. FOOD & DRUG ADMINISTRATION BLA 761308 COMPLETE RESPONSE Jiangsu Hengrui Pharmaceuticals Co., Ltd. c/o Hengrui U.S.A., Inc. Attention: Brahmaiah Kommanaboyina US Agent Head of U.S. Regulatory…
- Apiject Systems Corp. · NDA 219107
PN U.S. FOOD & DRUG ADMINISTRATION NDA 219107 COMPLETE RESPONSE Apiject Systems Corp. Attention: Ashley Dynan Senior Director of Regulatory Affairs 2 High Ridge Park Stamford, CT 06905 Dear Ashley Dy…
- Telix Pharmaceuticals (US) Inc. · BLA 761401
ADMINISTRATION g By) U.S. FOOD & DRUG ioe BLA 761401 CORRECTED COMPLETE RESPONSE Telix Pharmaceuticals (US) Inc. Attention: Yvonne Chow Global Regulatory Affairs Manager 11700 Exit 5 Pkwy Suite 200 F…
- Eagle Pharmaceuticals, Inc. · NDA 220045
yy U.S. FOOD & DRUG ADMINISTRATION NDA 220045 COMPLETE RESPONSE Eagle Pharmaceuticals, Inc. Attention: Janis A. Picurro Senior Vice President, Regulatory Affairs 50 Tice Boulevard, Suite 315 Woodclif…
- Fresenius Kabi USA, LLC · NDA 215818
U.S. FOOD & DRUG Sy ADMINISTRATION NDA 215818 COMPLETE RESPONSE Fresenius Kabi USA, LLC Attention: Jennifer Gross, MS Senior Regulatory Affairs Associate Three Corporate Drive Lake Zurich, IL 60047 D…
- Pierre Fabre Pharmaceuticals Inc. · BL 125745
i Lg YN U.S. FOOD & DRUG ADMINISTRATION Our STN: BL 125745/0 COMPLETE RESPONSE January 9, 2026 Pierre Fabre Pharmaceuticals Inc. Attention: Lana Klionsky 500 Plaza Drive, Suite 701B Secaucus, NJ 0709…
- Disc Medicine, Inc. · NDA 220707
PN U.S. FOOD & DRUG ADMINISTRATION NDA 220707 COMPLETE RESPONSE Disc Medicine, Inc. Attention: Steve Caffé, MD Chief Regulatory Officer 321 Arsenal Street, Suite 101 Watertown, MA 02472 Dear Dr. Caff…
- Bridge Regulatory Affairs, LLC · NDA 218600
yy U.S. FOOD & DRUG ADMINISTRATION NDA 218600 COMPLETE RESPONSE Bridge Regulatory Affairs, LLC U.S. Agent for Camurus AB Attention: Bridgette Kunst, MA, RAC 148 Butler Road Franklin Park, NJ 08823 De…
- Aquestive Therapeutics Inc. · NDA 219870
YN U.S. FOOD & DRUG ADMINISTRATION NDA 219870 COMPLETE RESPONSE Aquestive Therapeutics Inc. Attention: Melina Cioffi, PharmD Vice President, Regulatory Affairs 30 Technology Drive Warren, NJ 07059 De…
- Aldeyra Therapeutics, Inc. · NDA 216442
ADMINISTRATION ( Lg YN U.S. FOOD & DRUG NDA 216442 COMPLETE RESPONSE Aldeyra Therapeutics, Inc. Attention: David Noskowitz Regulatory Affairs Consultant 131 Hartwell Ave., Suite 320 Lexington, MA 024…
- Rosemont Pharmaceuticals Holdings, Inc. · NDA 220140
i Lk YN U.S. FOOD & DRUG ADMINISTRATION NDA 220140 COMPLETE RESPONSE Rosemont Pharmaceuticals Holdings, Inc. c/o Hyloris Developments SA (an affiliate of Dermax) Attention: Kristi Norris, PhD VP, Reg…
- Ascelia Pharma AB · NDA 220544
yy U.S. FOOD & DRUG ADMINISTRATION NDA 220544 COMPLETE RESPONSE Ascelia Pharma AB c/o Syneos Health Attention: Anju Mainra Senior Director Global Regulatory Affairs Solutions 1030 Sync Street Morrisv…
- Ferring Pharmaceuticals Inc. · BLA 761253
PrN U.S. FOOD & DRUG ADMINISTRATION BLA 761253 COMPLETE RESPONSE Ferring Pharmaceuticals Inc. Attention: Sangeeta Chavan Patil Director, Regulatory Affairs 100 Interpace Parkway Parsippany, NJ 07054…
- Amphastar Pharmaceuticals, Inc. · BLA 761403
PN U.S. FOOD & DRUG ADMINISTRATION BLA 761403 COMPLETE RESPONSE Amphastar Pharmaceuticals, Inc. Attention: Magda Albedrop, RAC-Drugs Senior Supervisor of the CMC and Submissions Group Regulatory Affa…
Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.
Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.