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 1357-1368 of 1503 letters

ALApproval Letter
Approval Letter NOVITIUM PHARMA (Feb 11, 2026)
FDA issued an approval letter for TAPENTADOL HYDROCHLORIDE on 2026-02-11. The source metadata identifies ANDA 219119 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 11, 2026
US FDA• TAPENTADOL HYDROCHLORIDE
TATentative Approval Letter
Tentative Approval Letter BPI LABS LLC (Feb 11, 2026)
FDA issued a tentative approval letter for SELENIOUS ACID on 2026-02-11. The source metadata identifies ANDA 220051 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 11, 2026
US FDA• SELENIOUS ACID
TATentative Approval Letter
Tentative Approval Letter HETERO LABS LIMITED (Feb 11, 2026)
FDA issued a tentative approval letter for ANDA 220525 on 2026-02-11. The source metadata identifies ANDA 220525 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 11, 2026
US FDA• ANDA 220525
TATentative Approval Letter
Tentative Approval Letter GRANULES PHARMACEUTICALS INC (Feb 11, 2026)
FDA issued a tentative approval letter for AMPHETAMINE on 2026-02-11. The source metadata identifies ANDA 220284 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 11, 2026
US FDA• AMPHETAMINE
ALApproval Letter
Approval Letter MANKIND PHARMA (Feb 11, 2026)
FDA issued an approval letter for TICAGRELOR on 2026-02-11. The source metadata identifies ANDA 217679 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 11, 2026
US FDA• TICAGRELOR
WLWarning Letter
Warning Letter Dynamic Stem Cell Therapy (Feb 11, 2026)
FDA issued a warning letter to Dynamic Stem Cell Therapy concerning Unapproved New Drugs/Unlicensed Biological Product Violations. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.
IssuedFeb 11, 2026
US FDA• Unapproved New Drugs/Unlicensed Biological Product Violations
ALApproval Letter
Approval Letter SUN PHARM INDS INC (Feb 10, 2026)
FDA issued an approval letter for ABSORICA, ABSORICA LD on 2026-02-10. The source metadata identifies NDA 021951, NDA 211913 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 10, 2026
US FDA• ABSORICA / ABSORICA LD
ALApproval Letter
Approval Letter HIKMA (Feb 10, 2026)
FDA issued an approval letter for REGLAN on 2026-02-10. The source metadata identifies NDA 017862 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 10, 2026
US FDA• REGLAN
ALApproval Letter
Approval Letter ANI PHARMS (Feb 10, 2026)
FDA issued an approval letter for REGLAN on 2026-02-10. The source metadata identifies NDA 017854 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 10, 2026
US FDA• REGLAN
ALApproval Letter
Approval Letter QOL MEDCL (Feb 10, 2026)
FDA issued an approval letter for GIMOTI on 2026-02-10. The source metadata identifies NDA 209388 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 10, 2026
US FDA• GIMOTI
WLWarning Letter
Warning Letter ProDx Health (Feb 10, 2026)
FDA issued a warning letter to ProDx Health concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). Deterministic source-metadata screening identifies discussion of 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.
IssuedFeb 10, 2026
US FDA• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
WLWarning Letter
Warning Letter Hearthy Foods, Inc. (Feb 10, 2026)
FDA issued a warning letter to Hearthy Foods, Inc. concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, 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 10, 2026
US FDA• CGMP/Dietary Supplement/Adulterated/Misbranded

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Approval Letter NOVITIUM PHARMA (Feb 11, 2026)

Tentative Approval Letter BPI LABS LLC (Feb 11, 2026)

Tentative Approval Letter HETERO LABS LIMITED (Feb 11, 2026)

Tentative Approval Letter GRANULES PHARMACEUTICALS INC (Feb 11, 2026)

Approval Letter MANKIND PHARMA (Feb 11, 2026)

Warning Letter Dynamic Stem Cell Therapy (Feb 11, 2026)

Approval Letter SUN PHARM INDS INC (Feb 10, 2026)

Approval Letter HIKMA (Feb 10, 2026)

Approval Letter ANI PHARMS (Feb 10, 2026)

Approval Letter QOL MEDCL (Feb 10, 2026)

Warning Letter ProDx Health (Feb 10, 2026)

Warning Letter Hearthy Foods, Inc. (Feb 10, 2026)