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 1429-1440 of 1503 letters

ALApproval Letter
Approval Letter APOTEX (Jan 26, 2026)
FDA issued an approval letter for CALDOLOR on 2026-01-26. The source metadata identifies NDA 022348 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 26, 2026
US FDA• CALDOLOR
ALApproval Letter
Approval Letter JANSSEN PHARMS (Jan 26, 2026)
FDA issued an approval letter for SPRAVATO on 2026-01-26. The source metadata identifies NDA 211243 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 26, 2026
US FDA• SPRAVATO
ALApproval Letter
Approval Letter SHORLA (Jan 23, 2026)
FDA issued an approval letter for TEPYLUTE on 2026-01-23. The source metadata identifies NDA 216984 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 23, 2026
US FDA• TEPYLUTE
ALApproval Letter
Approval Letter UCB INC (Jan 23, 2026)
FDA issued an approval letter for ZILBRYSQ on 2026-01-23. The source metadata identifies NDA 216834 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 23, 2026
US FDA• ZILBRYSQ
WLWarning Letter
Warning Letter Abbott Diabetes Care, Inc. (Jan 23, 2026)
FDA issued a warning letter to Abbott Diabetes Care, Inc. concerning CGMP/QSR/Medical Devices/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.
IssuedJan 23, 2026
US FDA• CGMP/QSR/Medical Devices/Adulterated
WLWarning Letter
Warning Letter Intelligent Remedies, Inc. (Jan 23, 2026)
FDA issued a warning letter to Intelligent Remedies, 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 23, 2026
US FDA• New Drug/Misbranded
WLWarning Letter
Warning Letter Louisville Reproductive Center (Jan 23, 2026)
FDA issued a warning letter to Louisville Reproductive Center concerning Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps). No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.
IssuedJan 23, 2026
US FDA• Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
ALApproval Letter
Approval Letter TG THERAPEUTICS, INC (Jan 22, 2026)
FDA issued an approval letter for BRIUMVI on 2026-01-22. The source metadata identifies BLA 761238 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 22, 2026
US FDA• BRIUMVI
ALApproval Letter
Approval Letter B BRAUN (Jan 22, 2026)
FDA issued 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. The source metadata identifies NDA 019708 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 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 issued an approval letter for VERQUVO on 2026-01-22. The source metadata identifies NDA 214377 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 22, 2026
US FDA• VERQUVO
ALApproval Letter
Approval Letter SHANDONG LUYE (Jan 22, 2026)
FDA issued an approval letter for RYKINDO on 2026-01-22. The source metadata identifies NDA 212849 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 22, 2026
US FDA• RYKINDO
ALApproval Letter
Approval Letter GENENTECH INC (Jan 22, 2026)
FDA issued an approval letter for EVRYSDI on 2026-01-22. The source metadata identifies NDA 219285, NDA 213535 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 22, 2026
US FDA• EVRYSDI

Page 120 of 126

1…118 119 120 121 122…126

Approval Letter APOTEX (Jan 26, 2026)

Approval Letter JANSSEN PHARMS (Jan 26, 2026)

Approval Letter SHORLA (Jan 23, 2026)

Approval Letter UCB INC (Jan 23, 2026)

Warning Letter Abbott Diabetes Care, Inc. (Jan 23, 2026)

Warning Letter Intelligent Remedies, Inc. (Jan 23, 2026)

Warning Letter Louisville Reproductive Center (Jan 23, 2026)

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)