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 841-852 of 1819 letters

ALApproval Letter
Approval Letter MERZ PHARMS (Jun 29, 2026)
FDA posted an approval letter for Xeomin on 2026-06-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125360 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 29, 2026
US FDA• Xeomin
ALApproval Letter
Approval Letter INSMED INC (Jun 29, 2026)
FDA posted an approval letter for ARIKAYCE KIT on 2026-06-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207356 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 29, 2026
US FDA• ARIKAYCE KIT
ALApproval Letter
Approval Letter KING PHARMS LLC (Jun 29, 2026)
FDA posted an approval letter for BICILLIN C-R, BICILLIN C-R 900/300, BICILLIN L-A on 2026-06-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050138, NDA 050141 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 29, 2026
US FDA• BICILLIN C-R / BICILLIN C-R 900/300 / BICILLIN L-A
ALApproval Letter
Approval Letter HALEON US HOLDINGS (Jun 29, 2026)
FDA posted an approval letter for CHILDREN'S ADVIL, CHILDREN'S ADVIL-FLAVORED on 2026-06-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020589 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 29, 2026
US FDA• CHILDREN'S ADVIL / CHILDREN'S ADVIL-FLAVORED
ALApproval Letter
Approval Letter PHARMAESSENTIA CORP (Jun 29, 2026)
FDA posted an approval letter for BESREMI on 2026-06-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761166 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 29, 2026
US FDA• BESREMI
WLWarning Letter
Warning Letter Balkanica LLC (Jun 29, 2026)
FDA issued a warning letter to Balkanica 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.
IssuedJun 29, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
ALApproval Letter
Approval Letter STEMLINE THERAP (Jun 26, 2026)
FDA posted an approval letter for ORSERDU on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217639 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 26, 2026
US FDA• ORSERDU
ALApproval Letter
Approval Letter PFIZER (Jun 26, 2026)
FDA posted an approval letter for IBRANCE on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212436 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 26, 2026
US FDA• IBRANCE
ALApproval Letter
Approval Letter PFIZER (Jun 26, 2026)
FDA posted an approval letter for IBRANCE on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207103 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 26, 2026
US FDA• IBRANCE
ALApproval Letter
Approval Letter MERCK SHARP DOHME (Jun 26, 2026)
FDA posted an approval letter for KEYTRUDA on 2026-06-26. 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 FDAJun 26, 2026
US FDA• KEYTRUDA
ALApproval Letter
Approval Letter IMMUNOMEDICS INC (Jun 26, 2026)
FDA posted an approval letter for TRODELVY on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761115 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 26, 2026
US FDA• TRODELVY
ALApproval Letter
Approval Letter JANSSEN PHARMS (Jun 26, 2026)
FDA posted an approval letter for SPRAVATO on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211243 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 26, 2026
US FDA• SPRAVATO

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Approval Letter MERZ PHARMS (Jun 29, 2026)

Approval Letter INSMED INC (Jun 29, 2026)

Approval Letter KING PHARMS LLC (Jun 29, 2026)

Approval Letter HALEON US HOLDINGS (Jun 29, 2026)

Approval Letter PHARMAESSENTIA CORP (Jun 29, 2026)

Warning Letter Balkanica LLC (Jun 29, 2026)

Approval Letter STEMLINE THERAP (Jun 26, 2026)

Approval Letter PFIZER (Jun 26, 2026)

Approval Letter PFIZER (Jun 26, 2026)

Approval Letter MERCK SHARP DOHME (Jun 26, 2026)

Approval Letter IMMUNOMEDICS INC (Jun 26, 2026)

Approval Letter JANSSEN PHARMS (Jun 26, 2026)