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 1,819 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 1753-1764 of 1819 letters

ALApproval Letter
Approval Letter TG THERAPEUTICS, INC (Jan 22, 2026)
FDA posted an approval letter for BRIUMVI on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761238 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 22, 2026
US FDA• BRIUMVI
ALApproval Letter
Approval Letter B BRAUN (Jan 22, 2026)
FDA posted an approval letter for POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019708 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 22, 2026
US FDA• POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ALApproval Letter
Approval Letter MSD (Jan 22, 2026)
FDA posted an approval letter for VERQUVO on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214377 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 22, 2026
US FDA• VERQUVO
ALApproval Letter
Approval Letter SHANDONG LUYE (Jan 22, 2026)
FDA posted an approval letter for RYKINDO on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212849 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 22, 2026
US FDA• RYKINDO
ALApproval Letter
Approval Letter GENENTECH INC (Jan 22, 2026)
FDA posted an approval letter for EVRYSDI on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219285, NDA 213535 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 22, 2026
US FDA• EVRYSDI
ALApproval Letter
Approval Letter FRESENIUS KABI USA (Jan 22, 2026)
FDA posted an approval letter for TYENNE on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761275 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 22, 2026
US FDA• TYENNE
ALApproval Letter
Approval Letter ADC Therapeutics SA (Jan 22, 2026)
FDA posted an approval letter for ZYNLONTA on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761196 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 22, 2026
US FDA• ZYNLONTA
ALApproval Letter
Approval Letter ORGANON (Jan 22, 2026)
FDA posted an approval letter for IMPLANON, NEXPLANON on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021529 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 22, 2026
US FDA• IMPLANON / NEXPLANON
ALApproval Letter
Approval Letter EISAI INC (Jan 22, 2026)
FDA posted an approval letter for LEQEMBI on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761269 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 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 full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding, Unapproved products and premarket authorization. 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 full-text screening identifies discussion of Food safety and supplier verification, 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.
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

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Approval Letter TG THERAPEUTICS, INC (Jan 22, 2026)

Approval Letter B BRAUN (Jan 22, 2026)

Approval Letter MSD (Jan 22, 2026)

Approval Letter SHANDONG LUYE (Jan 22, 2026)

Approval Letter GENENTECH INC (Jan 22, 2026)

Approval Letter FRESENIUS KABI USA (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)