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 409-420 of 1819 letters

ALApproval Letter
Approval Letter BAXTER HLTHCARE CORP (Sep 28, 2026)
FDA posted an approval letter for DAPZURA RT, DAPTOMYCIN IN 0.9% SODIUM CHLORIDE on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213645 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 28, 2026
US FDA• DAPZURA RT / DAPTOMYCIN IN 0.9% SODIUM CHLORIDE
ALApproval Letter
Approval Letter IRONSHORE PHARMS (Sep 28, 2026)
FDA posted an approval letter for JORNAY PM on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209311 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 28, 2026
US FDA• JORNAY PM
ALApproval Letter
Approval Letter ELEVAR THERAPEUTICS INC (Sep 25, 2026)
FDA posted an approval letter for LYRFIGTU on 2026-09-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220425 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 25, 2026
US FDA• LYRFIGTU
ALApproval Letter
Approval Letter APOTEX (Sep 25, 2026)
FDA posted an approval letter for PAXIL, PAXIL CR on 2026-09-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020031, NDA 020710, NDA 020936 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 25, 2026
US FDA• PAXIL / PAXIL CR
ALApproval Letter
Approval Letter HORIZON THERAPEUTICS IRELAND (Sep 25, 2026)
FDA posted an approval letter for TEPEZZA on 2026-09-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761143 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 25, 2026
US FDA• TEPEZZA
ALApproval Letter
Approval Letter ASTRAZENECA (Sep 25, 2026)
FDA posted an approval letter for CRESTOR on 2026-09-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021366 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 25, 2026
US FDA• CRESTOR
ALApproval Letter
Approval Letter ELI LILLY AND CO (Sep 25, 2026)
FDA posted an approval letter for ONSWIK on 2026-09-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761408 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 25, 2026
US FDA• ONSWIK
WLWarning Letter
Warning Letter sfshoply.com (Sep 25, 2026)
FDA issued a warning letter to sfshoply.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.
IssuedSep 25, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
ALApproval Letter
Approval Letter STRIDES PHARMA INTL (Sep 24, 2026)
FDA posted an approval letter for METHOTREXATE SODIUM on 2026-09-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 008085 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 24, 2026
US FDA• METHOTREXATE SODIUM
WLWarning Letter
Warning Letter Cheap Medicine Shop/www.cheapmedicineshop.com (Sep 24, 2026)
FDA issued a warning letter to Cheap Medicine Shop/www.cheapmedicineshop.com concerning Unapproved New Drugs/Misbranded (Internet Pharmacy). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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.
IssuedSep 24, 2026
US FDA• Unapproved New Drugs/Misbranded (Internet Pharmacy)
ALApproval Letter
Approval Letter CARMEL BIOSCIENCES (Sep 23, 2026)
FDA posted an approval letter for PREXXARTAN on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209139 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 23, 2026
US FDA• PREXXARTAN
ALApproval Letter
Approval Letter BAYER HEALTHCARE (Sep 23, 2026)
FDA posted an approval letter for NUBEQA on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212099 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 23, 2026
US FDA• NUBEQA

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Approval Letter BAXTER HLTHCARE CORP (Sep 28, 2026)

Approval Letter IRONSHORE PHARMS (Sep 28, 2026)

Approval Letter ELEVAR THERAPEUTICS INC (Sep 25, 2026)

Approval Letter APOTEX (Sep 25, 2026)

Approval Letter HORIZON THERAPEUTICS IRELAND (Sep 25, 2026)

Approval Letter ASTRAZENECA (Sep 25, 2026)

Approval Letter ELI LILLY AND CO (Sep 25, 2026)

Warning Letter sfshoply.com (Sep 25, 2026)

Approval Letter STRIDES PHARMA INTL (Sep 24, 2026)

Warning Letter Cheap Medicine Shop/www.cheapmedicineshop.com (Sep 24, 2026)

Approval Letter CARMEL BIOSCIENCES (Sep 23, 2026)

Approval Letter BAYER HEALTHCARE (Sep 23, 2026)