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 889-900 of 1503 letters

ALApproval Letter
Approval Letter MERUS N.V. (May 11, 2026)
FDA issued an approval letter for BIZENGRI on 2026-05-11. The source metadata identifies BLA 761352 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 11, 2026
US FDA• BIZENGRI
ALApproval Letter
Approval Letter KING PHARMS LLC (May 11, 2026)
FDA issued an approval letter for ALTACE on 2026-05-11. The source metadata identifies NDA 019901 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 11, 2026
US FDA• ALTACE
ALApproval Letter
Approval Letter VALEANT LUXEMBOURG (May 11, 2026)
FDA issued an approval letter for SILIQ on 2026-05-11. The source metadata identifies BLA 761032 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 11, 2026
US FDA• SILIQ
ALApproval Letter
Approval Letter ABBVIE ENDOCRINE INC (May 8, 2026)
FDA issued an approval letter for LUPRON on 2026-05-08. The source metadata identifies NDA 019010 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 8, 2026
US FDA• LUPRON
ALApproval Letter
Approval Letter TERSERA (May 8, 2026)
FDA issued an approval letter for ZOLADEX on 2026-05-08. The source metadata identifies NDA 020578 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 8, 2026
US FDA• ZOLADEX
ALApproval Letter
Approval Letter TOLMAR (May 8, 2026)
FDA issued an approval letter for ELIGARD KIT on 2026-05-08. The source metadata identifies NDA 021343, NDA 021379, NDA 021488, NDA 021731 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 8, 2026
US FDA• ELIGARD KIT
ALApproval Letter
Approval Letter ENDO OPERATIONS (May 8, 2026)
FDA issued an approval letter for VANTAS on 2026-05-08. The source metadata identifies NDA 021732 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 8, 2026
US FDA• VANTAS
ALApproval Letter
Approval Letter TERSERA (May 8, 2026)
FDA issued an approval letter for ZOLADEX on 2026-05-08. The source metadata identifies NDA 019726, NDA 020515 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 8, 2026
US FDA• ZOLADEX
ALApproval Letter
Approval Letter JANSSEN BIOTECH (May 8, 2026)
FDA issued an approval letter for TECVAYLI, TALVEY on 2026-05-08. The source metadata identifies BLA 761291, BLA 761342 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 8, 2026
US FDA• TECVAYLI / TALVEY
WLWarning Letter
Warning Letter ct-riecig.com (May 8, 2026)
FDA issued a warning letter to ct-riecig.com 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. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 8, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter waterbedsnstuff.com (May 8, 2026)
FDA issued a warning letter to waterbedsnstuff.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Tobacco product authorization and marketing, 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.
IssuedMay 8, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
ALApproval Letter
Approval Letter AXSOME (May 6, 2026)
FDA issued an approval letter for AUVELITY on 2026-05-06. The source metadata identifies NDA 215430 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 6, 2026
US FDA• AUVELITY

Page 75 of 126

1…73 74 75 76 77…126

Approval Letter MERUS N.V. (May 11, 2026)

Approval Letter KING PHARMS LLC (May 11, 2026)

Approval Letter VALEANT LUXEMBOURG (May 11, 2026)

Approval Letter ABBVIE ENDOCRINE INC (May 8, 2026)

Approval Letter TERSERA (May 8, 2026)

Approval Letter TOLMAR (May 8, 2026)

Approval Letter ENDO OPERATIONS (May 8, 2026)

Approval Letter TERSERA (May 8, 2026)

Approval Letter JANSSEN BIOTECH (May 8, 2026)

Warning Letter ct-riecig.com (May 8, 2026)

Warning Letter waterbedsnstuff.com (May 8, 2026)

Approval Letter AXSOME (May 6, 2026)