Complete response letters
FDA's letters telling drug and biologic applicants why an application was not approved as submitted. 458 records; openFDA updated it 2026-09-23. About this dataset
Newest records
- Approved309
- Unapproved149
- Grace Therapeutics U.S., Inc. · NDA 220304
g U.S. FOOD & DRUG Naty ADMINISTRATION NDA 220304 COMPLETE RESPONSE Grace Therapeutics U.S., Inc. Attention: Amresh Kumar Vice President of Program Management 103 Carnegie Center Drive, Suite 300 Pri…
- 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…
- 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…
- 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…
- 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…
- Achieve Life Sciences, Inc. · NDA 218995
ADMINISTRATION i Lk YN U.S. FOOD & DRUG NDA 218995 COMPLETE RESPONSE Achieve Life Sciences, Inc. 22722 29th Dr. SE, Suite 100 Bothell, WA 98021 Attention: | Sarah Telzrow Vice President, Regulatory A…
- Tris Pharma, Inc. · NDA 220138
i Lk YN U.S. FOOD & DRUG ADMINISTRATION NDA 220138 COMPLETE RESPONSE Tris Pharma, Inc. Attention: Rashmi Aravind Senior Director of Regulatory Affairs 2033 Route 130 Suite #D Monmouth Junction, NJ 08…
- Evergreen Theragnostics, Inc. · NDA 216900
PN U.S. FOOD & DRUG ADMINISTRATION NDA 216900 COMPLETE RESPONSE Evergreen Theragnostics, Inc. C/o Bourque Regulatory CMC, Inc. Attention: Mr. Jeffrey Bourque President, Bourque Regulatory CMC, Inc. 2…
- Swedish Orphan Biovitrum AB (publ) · BLA 761438
g U.S. FOOD & DRUG x ADMINISTRATION BLA 761438 COMPLETE RESPONSE Swedish Orphan Biovitrum AB (publ) Attention: Bao Le US Regulatory Lead, Immunology 77 4th Avenue, 3 Floor Waltham, MA 02451 Dear Bao…
- AbbVie Inc. · BLA 761459
nN U.S. FOOD & DRUG ADMINISTRATION BLA 761459 COMPLETE RESPONSE AbbVie Inc. Attention: Felipe Martins Associate Director, Regulatory Affairs 2525 Dupont Drive Irvine, CA 92612 Dear Felipe Martins: Pl…
- Tanvex BioPharma USA, Inc. · BLA 761266
i Lk YN U.S. FOOD & DRUG ADMINISTRATION BLA 761266 COMPLETE RESPONSE Tanvex BioPharma USA, Inc. Attention: Bonnie J. Mills, PhD 10394 Pacific Center Court San Diego, CA 92121 Dear Dr. Mills: Please r…
- Ocuvex Therapeutics, Inc. · NDA 217363
yy U.S. FOOD & DRUG ADMINISTRATION NDA 217363 COMPLETE RESPONSE Ocuvex Therapeutics, Inc. Attention: Anthony Amato Chief Executive Officer 1 Bridge Plaza, Second Floor Fort Lee, NJ 07024 Dear Anthony…
- ITM Solucin GmbH · NDA 218705
g U.S. FOOD & DRUG Naty ADMINISTRATION NDA 218705 COMPLETE RESPONSE ITM Solucin GmbH c/o Lumara Bio USA Inc. Attention: Tinya Sow, MHA US Agent, Director - US, Regulatory Lead 5 Vaughn Drive, Suite 3…
- Cingulate Therapeutics, LLC · NDA 220283
g U.S. FOOD & DRUG Naty ADMINISTRATION NDA 220283 COMPLETE RESPONSE Cingulate Therapeutics, LLC Attention: Kelly R. Koehn Vice President, Clinical and Regulatory Operations 1901 W. 47" Place Westwood…
- REGENXBIO, Inc. · BL 125840
g YN U.S. FOOD & DRUG ADMINISTRATION Our STN: BL 125840/0 COMPLETE RESPONSE February 7, 2026 REGENXBIO, Inc. Attention: Steve Pakola, MD 9804 Medical Center Drive Rockville, MD 20850 Dear Dr. Pakola:…
- Replimune, Inc. · BL 125827
i Lk Fy" U.S. FOOD & DRUG ADMINISTRATION Our STN: BL 125827 COMPLETE RESPONSE APRIL 10, 2026 Replimune, Inc. Attention: Kari Jeschke 500 Unicorn Park Drive Woburn, MA 01801 Dear Kari Jeschke: Please…
- 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…
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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.