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 1,503 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 721-732 of 1503 letters

ALApproval Letter
Approval Letter ASTRAZENECA AB (Jun 5, 2026)
FDA issued an approval letter for FASENRA on 2026-06-05. The source metadata identifies BLA 761070 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 5, 2026
US FDA• FASENRA
ALApproval Letter
Approval Letter MSD SUB MERCK (Jun 5, 2026)
FDA issued an approval letter for STEGLATRO on 2026-06-05. The source metadata identifies NDA 209803 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 5, 2026
US FDA• STEGLATRO
ALApproval Letter
Approval Letter ASTRAZENECA AB (Jun 5, 2026)
FDA issued an approval letter for FARXIGA on 2026-06-05. The source metadata identifies NDA 202293 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 5, 2026
US FDA• FARXIGA
ALApproval Letter
Approval Letter ASTRAZENECA AB (Jun 5, 2026)
FDA issued an approval letter for QTERN on 2026-06-05. The source metadata identifies NDA 209091 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 5, 2026
US FDA• QTERN
ALApproval Letter
Approval Letter SANDOZ (Jun 5, 2026)
FDA issued an approval letter for ARGATROBAN IN DEXTROSE on 2026-06-05. The source metadata identifies NDA 201743 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 5, 2026
US FDA• ARGATROBAN IN DEXTROSE
ALApproval Letter
Approval Letter JANSSEN PHARMS (Jun 5, 2026)
FDA issued an approval letter for INVOKANA on 2026-06-05. The source metadata identifies NDA 204042 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 5, 2026
US FDA• INVOKANA
ALApproval Letter
Approval Letter THERACOSBIO (Jun 5, 2026)
FDA issued an approval letter for BRENZAVVY on 2026-06-05. The source metadata identifies NDA 214373 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 5, 2026
US FDA• BRENZAVVY
WLWarning Letter
Warning Letter Imu-Tek Animal Health, Incorporated (Jun 5, 2026)
FDA issued a warning letter to Imu-Tek Animal Health, Incorporated concerning Dietary Supplement/New Drug/Misbranded. Deterministic full-text screening identifies discussion of 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.
IssuedJun 5, 2026
US FDA• Dietary Supplement/New Drug/Misbranded
WLWarning Letter
Warning Letter Mineral BioSciences, LLC (Jun 5, 2026)
FDA issued a warning letter to Mineral BioSciences, LLC concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of 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.
IssuedJun 5, 2026
US FDA• Unapproved New Drugs/Misbranded
WLWarning Letter
Warning Letter Sante Manufacturing Inc. (Jun 5, 2026)
FDA issued a warning letter to Sante Manufacturing Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJun 5, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter AseptiKits, LLC (Jun 4, 2026)
FDA issued a warning letter to AseptiKits, LLC concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. 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.
IssuedJun 4, 2026
US FDA• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
WLWarning Letter
Warning Letter Nutratech, LLC (Jun 4, 2026)
FDA issued a warning letter to Nutratech, LLC concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic source-metadata screening identifies discussion of Manufacturing and CGMP controls, 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.
IssuedJun 4, 2026
US FDA• CGMP/Dietary Supplement/Adulterated/Misbranded

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Approval Letter ASTRAZENECA AB (Jun 5, 2026)

Approval Letter MSD SUB MERCK (Jun 5, 2026)

Approval Letter ASTRAZENECA AB (Jun 5, 2026)

Approval Letter ASTRAZENECA AB (Jun 5, 2026)

Approval Letter SANDOZ (Jun 5, 2026)

Approval Letter JANSSEN PHARMS (Jun 5, 2026)

Approval Letter THERACOSBIO (Jun 5, 2026)

Warning Letter Imu-Tek Animal Health, Incorporated (Jun 5, 2026)

Warning Letter Mineral BioSciences, LLC (Jun 5, 2026)

Warning Letter Sante Manufacturing Inc. (Jun 5, 2026)

Warning Letter AseptiKits, LLC (Jun 4, 2026)

Warning Letter Nutratech, LLC (Jun 4, 2026)