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 769-780 of 1503 letters

WLWarning Letter
Warning Letter Laboratorios Dr. Collado S.A. (Jun 2, 2026)
FDA issued a warning letter to Laboratorios Dr. Collado S.A. concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJun 2, 2026
US FDA• CGMP/OTC Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Asanuma Corporation - Sagamihara Factory (Jun 2, 2026)
FDA issued a warning letter to Asanuma Corporation - Sagamihara Factory concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic source-metadata screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJun 2, 2026
US FDA• CGMP/OTC Finished Pharmaceuticals/Adulterated
ALApproval Letter
Approval Letter SHORLA (May 29, 2026)
FDA issued an approval letter for JYLAMVO on 2026-05-29. The source metadata identifies NDA 212479 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 29, 2026
US FDA• JYLAMVO
ALApproval Letter
Approval Letter ASTRAZENECA UK LTD (May 29, 2026)
FDA issued an approval letter for IMFINZI on 2026-05-29. The source metadata identifies BLA 761069 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 29, 2026
US FDA• IMFINZI
ALApproval Letter
Approval Letter STRIDES PHARMA INTL (May 29, 2026)
FDA issued an approval letter for METHOTREXATE SODIUM on 2026-05-29. The source metadata identifies NDA 008085 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 29, 2026
US FDA• METHOTREXATE SODIUM
ALApproval Letter
Approval Letter DELCATH SYSTEMS INC (May 29, 2026)
FDA issued an approval letter for HEPZATO on 2026-05-29. The source metadata identifies NDA 201848 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 29, 2026
US FDA• HEPZATO
ALApproval Letter
Approval Letter JANSSEN BIOTECH (May 29, 2026)
FDA issued an approval letter for TREMFYA on 2026-05-29. The source metadata identifies BLA 761061 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 29, 2026
US FDA• TREMFYA
ALApproval Letter
Approval Letter AZURITY (May 29, 2026)
FDA issued an approval letter for FERAHEME on 2026-05-29. The source metadata identifies NDA 022180 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 29, 2026
US FDA• FERAHEME
ALApproval Letter
Approval Letter GENENTECH INC (May 29, 2026)
FDA issued an approval letter for COLUMVI on 2026-05-29. The source metadata identifies BLA 761309 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 29, 2026
US FDA• COLUMVI
ALApproval Letter
Approval Letter ABBVIE INC (May 29, 2026)
FDA issued an approval letter for DECNUPAZ on 2026-05-29. The source metadata identifies BLA 761460 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 29, 2026
US FDA• DECNUPAZ
ALApproval Letter
Approval Letter ASTRAZENECA (May 29, 2026)
FDA issued an approval letter for TRUQAP on 2026-05-29. The source metadata identifies NDA 218197 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 29, 2026
US FDA• TRUQAP
ALApproval Letter
Approval Letter ORGANON (May 29, 2026)
FDA issued an approval letter for IMPLANON, NEXPLANON on 2026-05-29. The source metadata identifies NDA 021529 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 29, 2026
US FDA• IMPLANON / NEXPLANON

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Warning Letter Laboratorios Dr. Collado S.A. (Jun 2, 2026)

Warning Letter Asanuma Corporation - Sagamihara Factory (Jun 2, 2026)

Approval Letter SHORLA (May 29, 2026)

Approval Letter ASTRAZENECA UK LTD (May 29, 2026)

Approval Letter STRIDES PHARMA INTL (May 29, 2026)

Approval Letter DELCATH SYSTEMS INC (May 29, 2026)

Approval Letter JANSSEN BIOTECH (May 29, 2026)

Approval Letter AZURITY (May 29, 2026)

Approval Letter GENENTECH INC (May 29, 2026)

Approval Letter ABBVIE INC (May 29, 2026)

Approval Letter ASTRAZENECA (May 29, 2026)

Approval Letter ORGANON (May 29, 2026)