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 1573-1584 of 1819 letters

ALApproval Letter
Approval Letter ARS PHARMS OPERATION (Feb 27, 2026)
FDA posted an approval letter for NEFFY on 2026-02-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214697 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 27, 2026
US FDA• NEFFY
ALApproval Letter
Approval Letter CHIESI (Feb 27, 2026)
FDA posted an approval letter for JUXTAPID on 2026-02-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203858 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 27, 2026
US FDA• JUXTAPID
WLWarning Letter
Warning Letter thesnuslife.com (Feb 27, 2026)
FDA issued a warning letter to thesnuslife.com 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.
IssuedFeb 27, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter snushaven.com (Feb 27, 2026)
FDA issued a warning letter to snushaven.com 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.
IssuedFeb 27, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter idripejuice.com (Feb 27, 2026)
FDA issued a warning letter to idripejuice.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.
IssuedFeb 27, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter Rio Verde Food Service Inc. (Feb 27, 2026)
FDA issued a warning letter to Rio Verde Food Service Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. 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.
IssuedFeb 27, 2026
US FDA• Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
WLWarning Letter
Warning Letter Longhorn Vaccines and Diagnostics LLC (Feb 26, 2026)
FDA issued a warning letter to Longhorn Vaccines and Diagnostics LLC concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Medical device quality and reporting, Quality systems and CAPA, Labeling, claims, and misbranding, 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.
IssuedFeb 26, 2026
US FDA• CGMP/QSR/Medical Devices/Adulterated
ALApproval Letter
Approval Letter ADC Therapeutics SA (Feb 24, 2026)
FDA posted an approval letter for ZYNLONTA on 2026-02-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761196 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 24, 2026
US FDA• ZYNLONTA
ALApproval Letter
Approval Letter HERON THERAPS INC (Feb 24, 2026)
FDA posted an approval letter for SUSTOL on 2026-02-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022445 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 24, 2026
US FDA• SUSTOL
ALApproval Letter
Approval Letter AVYXA HOLDINGS (Feb 24, 2026)
FDA posted an approval letter for FAVLYXA on 2026-02-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220201 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 24, 2026
US FDA• FAVLYXA
ALApproval Letter
Approval Letter GUERBET (Feb 24, 2026)
FDA posted an approval letter for ELUCIREM on 2026-02-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216986 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 24, 2026
US FDA• ELUCIREM
ALApproval Letter
Approval Letter IMMEDICA PHARMA AB (Feb 24, 2026)
FDA posted an approval letter for LOARGYS on 2026-02-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761211 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 24, 2026
US FDA• LOARGYS

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Approval Letter ARS PHARMS OPERATION (Feb 27, 2026)

Approval Letter CHIESI (Feb 27, 2026)

Warning Letter thesnuslife.com (Feb 27, 2026)

Warning Letter snushaven.com (Feb 27, 2026)

Warning Letter idripejuice.com (Feb 27, 2026)

Warning Letter Rio Verde Food Service Inc. (Feb 27, 2026)

Warning Letter Longhorn Vaccines and Diagnostics LLC (Feb 26, 2026)

Approval Letter ADC Therapeutics SA (Feb 24, 2026)

Approval Letter HERON THERAPS INC (Feb 24, 2026)

Approval Letter AVYXA HOLDINGS (Feb 24, 2026)

Approval Letter GUERBET (Feb 24, 2026)

Approval Letter IMMEDICA PHARMA AB (Feb 24, 2026)