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 745-756 of 1819 letters

ALApproval Letter
Approval Letter PFIZER (Jul 20, 2026)
FDA posted an approval letter for ZITHROMAX on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050710, NDA 050784, NDA 050711 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 20, 2026
US FDA• ZITHROMAX
ALApproval Letter
Approval Letter PFIZER (Jul 20, 2026)
FDA posted an approval letter for ZITHROMAX on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050670, NDA 050730 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 20, 2026
US FDA• ZITHROMAX
ALApproval Letter
Approval Letter PFIZER (Jul 20, 2026)
FDA posted an approval letter for ZITHROMAX on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050733 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 20, 2026
US FDA• ZITHROMAX
ALApproval Letter
Approval Letter NOVA LABS LTD (Jul 20, 2026)
FDA posted an approval letter for PURIXAN on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205919 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 20, 2026
US FDA• PURIXAN
ALApproval Letter
Approval Letter ELI LILLY AND CO (Jul 20, 2026)
FDA posted an approval letter for VERZENIO on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208716 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 20, 2026
US FDA• VERZENIO
ALApproval Letter
Approval Letter MUNDIPHARMA (Jul 20, 2026)
FDA posted an approval letter for REZZAYO on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217417 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 20, 2026
US FDA• REZZAYO
ALApproval Letter
Approval Letter MEDUNIK (Jul 20, 2026)
FDA posted an approval letter for PHEBURANE on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216513 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 20, 2026
US FDA• PHEBURANE
WLWarning Letter
Warning Letter Fil-Bay Import, Inc. (Jul 20, 2026)
FDA issued a warning letter to Fil-Bay Import, 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 20, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter mkpodplug.co.uk (Jul 17, 2026)
FDA issued a warning letter to mkpodplug.co.uk concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJul 17, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
ALApproval Letter
Approval Letter CENTOCOR ORTHO BIOTECH INC (Jul 16, 2026)
FDA posted an approval letter for STELARA on 2026-07-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125261 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 16, 2026
US FDA• STELARA
ALApproval Letter
Approval Letter MSD (Jul 16, 2026)
FDA posted an approval letter for LIPFENDRA on 2026-07-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220848 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 16, 2026
US FDA• LIPFENDRA
ALApproval Letter
Approval Letter FERRING (Jul 16, 2026)
FDA posted an approval letter for ENDOMETRIN on 2026-07-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022057 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 16, 2026
US FDA• ENDOMETRIN

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Approval Letter PFIZER (Jul 20, 2026)

Approval Letter PFIZER (Jul 20, 2026)

Approval Letter PFIZER (Jul 20, 2026)

Approval Letter NOVA LABS LTD (Jul 20, 2026)

Approval Letter ELI LILLY AND CO (Jul 20, 2026)

Approval Letter MUNDIPHARMA (Jul 20, 2026)

Approval Letter MEDUNIK (Jul 20, 2026)

Warning Letter Fil-Bay Import, Inc. (Jul 20, 2026)

Warning Letter mkpodplug.co.uk (Jul 17, 2026)

Approval Letter CENTOCOR ORTHO BIOTECH INC (Jul 16, 2026)

Approval Letter MSD (Jul 16, 2026)

Approval Letter FERRING (Jul 16, 2026)