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 997-1008 of 1503 letters

ALApproval Letter
Approval Letter SANDOZ (Apr 14, 2026)
FDA issued an approval letter for TOBRADEX on 2026-04-14. The source metadata identifies NDA 050592 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 14, 2026
US FDA• TOBRADEX
WLWarning Letter
Warning Letter Pro Numb Tattoo Numbing Spray, LLC (Apr 14, 2026)
FDA issued a warning letter to Pro Numb Tattoo Numbing Spray, LLC concerning Nonprescription/OTC. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.
IssuedApr 14, 2026
US FDA• Nonprescription/OTC
WLWarning Letter
Warning Letter New Life Pharma LLC (Apr 14, 2026)
FDA issued a warning letter to New Life Pharma LLC concerning CGMP/Adulterated and Unapproved New Drug/Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, 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.
IssuedApr 14, 2026
US FDA• CGMP/Adulterated and Unapproved New Drug/Misbranded
WLWarning Letter
Warning Letter Ava Inc. (Apr 14, 2026)
FDA issued a warning letter to Ava Inc. concerning CGMP/Finished Pharmaceuticals/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.
IssuedApr 14, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
ALApproval Letter
Approval Letter JANSSEN PHARMS (Apr 13, 2026)
FDA issued an approval letter for CONCERTA on 2026-04-13. The source metadata identifies NDA 021121 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 13, 2026
US FDA• CONCERTA
WLWarning Letter
Warning Letter UCSF Radiopharmaceutical Facility (Apr 13, 2026)
FDA issued a warning letter to UCSF Radiopharmaceutical Facility concerning CGMP/Finished Pharmaceuticals/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.
IssuedApr 13, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
ALApproval Letter
Approval Letter THEA PHARMA (Apr 10, 2026)
FDA issued an approval letter for COSOPT PF on 2026-04-10. The source metadata identifies NDA 202667 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 10, 2026
US FDA• COSOPT PF
ALApproval Letter
Approval Letter GENENTECH INC (Apr 10, 2026)
FDA issued an approval letter for VABYSMO on 2026-04-10. The source metadata identifies BLA 761235 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 10, 2026
US FDA• VABYSMO
ALApproval Letter
Approval Letter BRISTOL (Apr 10, 2026)
FDA issued an approval letter for ONUREG on 2026-04-10. The source metadata identifies NDA 214120 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 10, 2026
US FDA• ONUREG
ALApproval Letter
Approval Letter SCIENTURE (Apr 10, 2026)
FDA issued an approval letter for REZENOPY on 2026-04-10. The source metadata identifies NDA 215487 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 10, 2026
US FDA• REZENOPY
WLWarning Letter
Warning Letter shopcalismokes.com (Apr 10, 2026)
FDA issued a warning letter to shopcalismokes.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.
IssuedApr 10, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter Fareva Amboise (Apr 10, 2026)
FDA issued a warning letter to Fareva Amboise concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Data integrity and records, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedApr 10, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated

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Approval Letter SANDOZ (Apr 14, 2026)

Warning Letter Pro Numb Tattoo Numbing Spray, LLC (Apr 14, 2026)

Warning Letter New Life Pharma LLC (Apr 14, 2026)

Warning Letter Ava Inc. (Apr 14, 2026)

Approval Letter JANSSEN PHARMS (Apr 13, 2026)

Warning Letter UCSF Radiopharmaceutical Facility (Apr 13, 2026)

Approval Letter THEA PHARMA (Apr 10, 2026)

Approval Letter GENENTECH INC (Apr 10, 2026)

Approval Letter BRISTOL (Apr 10, 2026)

Approval Letter SCIENTURE (Apr 10, 2026)

Warning Letter shopcalismokes.com (Apr 10, 2026)

Warning Letter Fareva Amboise (Apr 10, 2026)