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 1321-1332 of 1503 letters

ALApproval Letter
Approval Letter AVYXA HOLDINGS (Feb 18, 2026)
FDA issued an approval letter for AVOPEF on 2026-02-18. The source metadata identifies NDA 220200 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 18, 2026
US FDA• AVOPEF
ALApproval Letter
Approval Letter HARMONY (Feb 18, 2026)
FDA issued an approval letter for WAKIX on 2026-02-18. The source metadata identifies NDA 211150 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 18, 2026
US FDA• WAKIX
ALApproval Letter
Approval Letter AOP HLTH US (Feb 18, 2026)
FDA issued an approval letter for RAPIBLYK on 2026-02-18. The source metadata identifies NDA 217202 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 18, 2026
US FDA• RAPIBLYK
WLWarning Letter
Warning Letter Raw Bistro Inc. (Feb 17, 2026)
FDA issued a warning letter to Raw Bistro Inc. concerning CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/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.
IssuedFeb 17, 2026
US FDA• CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
ALApproval Letter
Approval Letter PFIZER (Feb 13, 2026)
FDA issued an approval letter for CLEOCIN PHOSPHATE, CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER on 2026-02-13. The source metadata identifies NDA 050441, NDA 050639 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 13, 2026
US FDA• CLEOCIN PHOSPHATE / CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ALApproval Letter
Approval Letter JANSSEN BIOTECH (Feb 13, 2026)
FDA issued an approval letter for DARZALEX FASPRO on 2026-02-13. The source metadata identifies BLA 761145 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 13, 2026
US FDA• DARZALEX FASPRO
ALApproval Letter
Approval Letter PFIZER (Feb 13, 2026)
FDA issued an approval letter for CLEOCIN HYDROCHLORIDE on 2026-02-13. The source metadata identifies NDA 050162 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 13, 2026
US FDA• CLEOCIN HYDROCHLORIDE
ALApproval Letter
Approval Letter ACROTECH BIOPHARMA (Feb 13, 2026)
FDA issued an approval letter for ADQUEY on 2026-02-13. The source metadata identifies NDA 219474 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 13, 2026
US FDA• ADQUEY
ALApproval Letter
Approval Letter KENVUE BRANDS (Feb 13, 2026)
FDA issued an approval letter for PEPCID AC on 2026-02-13. The source metadata identifies NDA 020325 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 13, 2026
US FDA• PEPCID AC
ALApproval Letter
Approval Letter ACCORD (Feb 13, 2026)
FDA issued an approval letter for CAMCEVI KIT on 2026-02-13. The source metadata identifies NDA 211488 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 13, 2026
US FDA• CAMCEVI KIT
ALApproval Letter
Approval Letter NOVARTIS (Feb 13, 2026)
FDA issued an approval letter for LEQVIO on 2026-02-13. The source metadata identifies NDA 214012 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 13, 2026
US FDA• LEQVIO
WLWarning Letter
Warning Letter The Sabagh Group Inc/lighterusa.com (Feb 13, 2026)
FDA issued a warning letter to The Sabagh Group Inc/lighterusa.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Unapproved products and premarket authorization, 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.
IssuedFeb 13, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

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Approval Letter AVYXA HOLDINGS (Feb 18, 2026)

Approval Letter HARMONY (Feb 18, 2026)

Approval Letter AOP HLTH US (Feb 18, 2026)

Warning Letter Raw Bistro Inc. (Feb 17, 2026)

Approval Letter PFIZER (Feb 13, 2026)

Approval Letter JANSSEN BIOTECH (Feb 13, 2026)

Approval Letter PFIZER (Feb 13, 2026)

Approval Letter ACROTECH BIOPHARMA (Feb 13, 2026)

Approval Letter KENVUE BRANDS (Feb 13, 2026)

Approval Letter ACCORD (Feb 13, 2026)

Approval Letter NOVARTIS (Feb 13, 2026)

Warning Letter The Sabagh Group Inc/lighterusa.com (Feb 13, 2026)