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 757-768 of 1819 letters

ALApproval Letter
Approval Letter NOVARTIS (Jul 16, 2026)
FDA posted an approval letter for TEGRETOL, TEGRETOL-XR on 2026-07-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 016608, NDA 018927, NDA 020234 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 16, 2026
US FDA• TEGRETOL / TEGRETOL-XR
WLWarning Letter
Warning Letter San Jorge Produce LLC (Jul 16, 2026)
FDA issued a warning letter to San Jorge Produce LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJul 16, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter Island Kinetics, Inc. d.b.a. CoValence Laboratories (Jul 16, 2026)
FDA issued a warning letter to Island Kinetics, Inc. d.b.a. CoValence Laboratories concerning CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Labeling, claims, and misbranding, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJul 16, 2026
US FDA• CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
ALApproval Letter
Approval Letter ELI LILLY AND CO (Jul 15, 2026)
FDA posted an approval letter for RETEVMO on 2026-07-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213246, NDA 218160 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 15, 2026
US FDA• RETEVMO
ALApproval Letter
Approval Letter EMD SERONO (Jul 15, 2026)
FDA posted an approval letter for SEROSTIM, SEROSTIM LQ on 2026-07-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 020604 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 15, 2026
US FDA• SEROSTIM / SEROSTIM LQ
ALApproval Letter
Approval Letter CELCUITY (Jul 15, 2026)
FDA posted an approval letter for REVTORPYK on 2026-07-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219908 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 15, 2026
US FDA• REVTORPYK
WLWarning Letter
Warning Letter LDNN Produce Inc. (Jul 15, 2026)
FDA issued a warning letter to LDNN Produce Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJul 15, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter AAL Trading Inc. (Jul 15, 2026)
FDA issued a warning letter to AAL Trading Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJul 15, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter Friend’s Stable and Orchard, Inc. (Jul 14, 2026)
FDA issued a warning letter to Friend’s Stable and Orchard, Inc. concerning Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.
IssuedJul 14, 2026
US FDA• Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated
ALApproval Letter
Approval Letter PROVEPHARM SAS (Jul 13, 2026)
FDA posted an approval letter for ZYOGREEN on 2026-07-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218579 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 13, 2026
US FDA• ZYOGREEN
ALApproval Letter
Approval Letter MERCK SHARP DOHME (Jul 13, 2026)
FDA posted an approval letter for KEYTRUDA on 2026-07-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 13, 2026
US FDA• KEYTRUDA
ALApproval Letter
Approval Letter MAINPOINTE (Jul 13, 2026)
FDA posted an approval letter for TUXARIN ER on 2026-07-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206323 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 13, 2026
US FDA• TUXARIN ER

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Approval Letter NOVARTIS (Jul 16, 2026)

Warning Letter San Jorge Produce LLC (Jul 16, 2026)

Warning Letter Island Kinetics, Inc. d.b.a. CoValence Laboratories (Jul 16, 2026)

Approval Letter ELI LILLY AND CO (Jul 15, 2026)

Approval Letter EMD SERONO (Jul 15, 2026)

Approval Letter CELCUITY (Jul 15, 2026)

Warning Letter LDNN Produce Inc. (Jul 15, 2026)

Warning Letter AAL Trading Inc. (Jul 15, 2026)

Warning Letter Friend’s Stable and Orchard, Inc. (Jul 14, 2026)

Approval Letter PROVEPHARM SAS (Jul 13, 2026)

Approval Letter MERCK SHARP DOHME (Jul 13, 2026)

Approval Letter MAINPOINTE (Jul 13, 2026)