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
6 records match “testosterone”
- Approved6
- Acer Therapeutics Inc. · NDA 214860
g YN U.S. FOOD & DRUG ADMINISTRATION NDA 214860 COMPLETE RESPONSE Acer Therapeutics Inc. Attention: Renée M. Carroll, MS, RAC Vice President, Head of Regulatory Affairs One Gateway Center, Suite 351…
- Marius Pharmaceuticals, LLC · NDA 213953
g YN U.S. FOOD & DRUG ADMINISTRATION NDA 213953 COMPLETE RESPONSE Marius Pharmaceuticals, LLC Attention: Om Dhingra, CEO 8601 Six Forks Road, Suite 630 Raleigh, NC 27615 Dear Mr. Dhingra: Please refe…
- Clarus Therapeutics, Inc. · NDA 206089
suing, ey i St DEPARTMENT OF HEALTH AND HUMAN SERVICES aaa Food and Drug Administration Silver Spring MD 20993 NDA 206089 COMPLETE RESPONSE Clarus Therapeutics, Inc. Attention: Robert E. Dudley, Ph.D…
- Antares Pharma, Inc. · NDA 209863
pute Mie OAL € DEPARTMENT OF HEALTH AND HUMAN SERVICES a. Food and Drug Administration Silver Spring MD 20993 NDA 209863 COMPLETE RESPONSE Antares Pharma, Inc. Attention: Nader Fotouhi, Ph.D. Directo…
- ELC Group · NDA 205054
ty : SA DEPARTMENT OF HEALTH AND HUMAN SERVICES "ena Food and Drug Administration Silver Spring MD 20993 NDA 205054 COMPLETE RESPONSE ELC Group Attention: Julia Valentine US Agent for GP Pharm, S.A.…
- Clarus Therapeutics, Inc. · NDA 206089
pute, Mie OAL 4 DEPARTMENT OF HEALTH AND HUMAN SERVICES NDA 206089 Food and Drug Administration Silver Spring MD 20993 COMPLETE RESPONSE Clarus Therapeutics, Inc. Attention: Robert E. Dudley, Ph.D. P…
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.