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 1441-1452 of 1503 letters

ALApproval Letter
Approval Letter FRESENIUS KABI USA (Jan 22, 2026)
FDA issued an approval letter for TYENNE on 2026-01-22. The source metadata identifies BLA 761275 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 22, 2026
US FDA• TYENNE
ALApproval Letter
Approval Letter CELLTRION INC (Jan 22, 2026)
FDA issued an approval letter for AVTOZMA on 2026-01-22. The source metadata identifies BLA 761498 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 22, 2026
US FDA• AVTOZMA
ALApproval Letter
Approval Letter ADC Therapeutics SA (Jan 22, 2026)
FDA issued an approval letter for ZYNLONTA on 2026-01-22. The source metadata identifies BLA 761196 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 22, 2026
US FDA• ZYNLONTA
ALApproval Letter
Approval Letter ORGANON (Jan 22, 2026)
FDA issued an approval letter for IMPLANON, NEXPLANON on 2026-01-22. The source metadata identifies NDA 021529 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 22, 2026
US FDA• IMPLANON / NEXPLANON
ALApproval Letter
Approval Letter EISAI INC (Jan 22, 2026)
FDA issued an approval letter for LEQEMBI on 2026-01-22. The source metadata identifies BLA 761269 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 22, 2026
US FDA• LEQEMBI
WLWarning Letter
Warning Letter Tombak LLC (Jan 22, 2026)
FDA issued a warning letter to Tombak LLC concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJan 22, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter South Bay Cold Storage & Handling, Inc. (Jan 22, 2026)
FDA issued a warning letter to South Bay Cold Storage & Handling, Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic source-metadata screening identifies discussion of Manufacturing and CGMP controls, Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJan 22, 2026
US FDA• Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
WLWarning Letter
Warning Letter Diamond-Herpanacine of PA, Inc. (Jan 22, 2026)
FDA issued a warning letter to Diamond-Herpanacine of PA, Inc. concerning New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJan 22, 2026
US FDA• New Drug/Misbranded
ALApproval Letter
Approval Letter BAUSCH AND LOMB (Jan 21, 2026)
FDA issued an approval letter for ZIRGAN on 2026-01-21. The source metadata identifies NDA 022211 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 21, 2026
US FDA• ZIRGAN
ALApproval Letter
Approval Letter ALEMBIC (Jan 21, 2026)
FDA issued an approval letter for LOTEPREDNOL ETABONATE AND TOBRAMYCIN on 2026-01-21. The source metadata identifies ANDA 217597 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 21, 2026
US FDA• LOTEPREDNOL ETABONATE AND TOBRAMYCIN
ALApproval Letter
Approval Letter ELI LILLY AND CO (Jan 21, 2026)
FDA issued an approval letter for ZEPBOUND (AUTOINJECTOR), ZEPBOUND, ZEPBOUND KWIKPEN on 2026-01-21. The source metadata identifies NDA 217806 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 21, 2026
US FDA• ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN
ALApproval Letter
Approval Letter ELI LILLY AND CO (Jan 21, 2026)
FDA issued an approval letter for MOUNJARO (AUTOINJECTOR), MOUNJARO, MOUNJARO KWIKPEN on 2026-01-21. The source metadata identifies NDA 215866 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 21, 2026
US FDA• MOUNJARO (AUTOINJECTOR) / MOUNJARO / MOUNJARO KWIKPEN

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Approval Letter FRESENIUS KABI USA (Jan 22, 2026)

Approval Letter CELLTRION INC (Jan 22, 2026)

Approval Letter ADC Therapeutics SA (Jan 22, 2026)

Approval Letter ORGANON (Jan 22, 2026)

Approval Letter EISAI INC (Jan 22, 2026)

Warning Letter Tombak LLC (Jan 22, 2026)

Warning Letter South Bay Cold Storage & Handling, Inc. (Jan 22, 2026)

Warning Letter Diamond-Herpanacine of PA, Inc. (Jan 22, 2026)

Approval Letter BAUSCH AND LOMB (Jan 21, 2026)

Approval Letter ALEMBIC (Jan 21, 2026)

Approval Letter ELI LILLY AND CO (Jan 21, 2026)

Approval Letter ELI LILLY AND CO (Jan 21, 2026)