FDA LETTER LIBRARY

FDA application & warning letters

Name: FDA Approval, Complete Response & Warning Letters
Creator: Assyro AI
License: https://www.usa.gov/government-works

Review 1,503 source-backed approval, tentative approval, complete response, and warning letters. Application letters cover 2026; the CRL corpus is complete as published by openFDA, and warning letters cover 2026.

Showing 373-384 of 1503 letters

ALApproval Letter
Approval Letter MERIDIAN BIOSCIENCE (Jul 28, 2026)
FDA issued an approval letter for IDKIT:HP on 2026-07-28. The source metadata identifies NDA 021314 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 28, 2026
US FDA• IDKIT:HP
ALApproval Letter
Approval Letter TEVA BRANDED PHARM (Jul 28, 2026)
FDA issued an approval letter for ZIAC on 2026-07-28. The source metadata identifies NDA 020186 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 28, 2026
US FDA• ZIAC
ALApproval Letter
Approval Letter ASTELLAS (Jul 28, 2026)
FDA issued an approval letter for XTANDI on 2026-07-28. The source metadata identifies NDA 203415, NDA 213674 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 28, 2026
US FDA• XTANDI
ALApproval Letter
Approval Letter ABBVIE (Jul 27, 2026)
FDA issued an approval letter for NORVIR on 2026-07-27. The source metadata identifies NDA 022417, NDA 209512 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 27, 2026
US FDA• NORVIR
ALApproval Letter
Approval Letter AETERNA ZENTARIS (Jul 27, 2026)
FDA issued an approval letter for MACRILEN on 2026-07-27. The source metadata identifies NDA 205598 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 27, 2026
US FDA• MACRILEN
ALApproval Letter
Approval Letter SANDOZ INC (Jul 27, 2026)
FDA issued an approval letter for TYRUKO on 2026-07-27. The source metadata identifies BLA 761322 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 27, 2026
US FDA• TYRUKO
ALApproval Letter
Approval Letter ABBVIE (Jul 27, 2026)
FDA issued an approval letter for KALETRA on 2026-07-27. The source metadata identifies NDA 021906, NDA 021251 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 27, 2026
US FDA• KALETRA
ALApproval Letter
Approval Letter AUROBINDO PHARMA LTD (Jul 24, 2026)
FDA issued an approval letter for BUPROPION HYDROCHLORIDE on 2026-07-24. The source metadata identifies ANDA 216051 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 24, 2026
US FDA• BUPROPION HYDROCHLORIDE
ALApproval Letter
Approval Letter NUVALENT INC (Jul 24, 2026)
FDA issued an approval letter for JIDEYTRO on 2026-07-24. The source metadata identifies NDA 220185 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 24, 2026
US FDA• JIDEYTRO
ALApproval Letter
Approval Letter BRISTOL MYERS SQUIBB (Jul 24, 2026)
FDA issued an approval letter for REVLIMID on 2026-07-24. The source metadata identifies NDA 021880 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 24, 2026
US FDA• REVLIMID
ALApproval Letter
Approval Letter KENVUE BRANDS (Jul 24, 2026)
FDA issued an approval letter for CHILDREN'S MOTRIN on 2026-07-24. The source metadata identifies NDA 020516 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 24, 2026
US FDA• CHILDREN'S MOTRIN
ALApproval Letter
Approval Letter LANTHEUS (Jul 24, 2026)
FDA issued an approval letter for NEURACEQ on 2026-07-24. The source metadata identifies NDA 204677 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 24, 2026
US FDA• NEURACEQ

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Approval Letter MERIDIAN BIOSCIENCE (Jul 28, 2026)

Approval Letter TEVA BRANDED PHARM (Jul 28, 2026)

Approval Letter ASTELLAS (Jul 28, 2026)

Approval Letter ABBVIE (Jul 27, 2026)

Approval Letter AETERNA ZENTARIS (Jul 27, 2026)

Approval Letter SANDOZ INC (Jul 27, 2026)

Approval Letter ABBVIE (Jul 27, 2026)

Approval Letter AUROBINDO PHARMA LTD (Jul 24, 2026)

Approval Letter NUVALENT INC (Jul 24, 2026)

Approval Letter BRISTOL MYERS SQUIBB (Jul 24, 2026)

Approval Letter KENVUE BRANDS (Jul 24, 2026)

Approval Letter LANTHEUS (Jul 24, 2026)