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 1669-1680 of 1819 letters

ALApproval Letter
Approval Letter GLAND (Feb 11, 2026)
FDA posted an approval letter for BORTEZOMIB on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219167 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 11, 2026
US FDA• BORTEZOMIB
TATentative Approval Letter
Tentative Approval Letter MYLAN PHARMACEUTICALS INC (Feb 11, 2026)
FDA posted a tentative approval letter for RIFAXIMIN on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219687 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 11, 2026
US FDA• RIFAXIMIN
ALApproval Letter
Approval Letter NOVAST LABS (Feb 11, 2026)
FDA posted an approval letter for CONJUGATED ESTROGENS on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 214025 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 11, 2026
US FDA• CONJUGATED ESTROGENS
ALApproval Letter
Approval Letter NOVAST LABS (Feb 11, 2026)
FDA posted an approval letter for CONJUGATED ESTROGENS on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 214023 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 11, 2026
US FDA• CONJUGATED ESTROGENS
ALApproval Letter
Approval Letter NOVITIUM PHARMA (Feb 11, 2026)
FDA posted an approval letter for TAPENTADOL HYDROCHLORIDE on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219119 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 11, 2026
US FDA• TAPENTADOL HYDROCHLORIDE
TATentative Approval Letter
Tentative Approval Letter BPI LABS LLC (Feb 11, 2026)
FDA posted a tentative approval letter for SELENIOUS ACID on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220051 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 11, 2026
US FDA• SELENIOUS ACID
TATentative Approval Letter
Tentative Approval Letter HETERO LABS LIMITED (Feb 11, 2026)
FDA posted a tentative approval letter for ANDA 220525 on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220525 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 11, 2026
US FDA• ANDA 220525
TATentative Approval Letter
Tentative Approval Letter GRANULES PHARMACEUTICALS INC (Feb 11, 2026)
FDA posted a tentative approval letter for AMPHETAMINE on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220284 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 11, 2026
US FDA• AMPHETAMINE
ALApproval Letter
Approval Letter MANKIND PHARMA (Feb 11, 2026)
FDA posted an approval letter for TICAGRELOR on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217679 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 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. 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.
IssuedFeb 11, 2026
US FDA• Unapproved New Drugs/Unlicensed Biological Product Violations
ALApproval Letter
Approval Letter SUN PHARM INDS INC (Feb 10, 2026)
FDA posted an approval letter for ABSORICA, ABSORICA LD on 2026-02-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021951, NDA 211913 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 10, 2026
US FDA• ABSORICA / ABSORICA LD
ALApproval Letter
Approval Letter HIKMA (Feb 10, 2026)
FDA posted an approval letter for REGLAN on 2026-02-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017862 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 10, 2026
US FDA• REGLAN

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Approval Letter GLAND (Feb 11, 2026)

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

Approval Letter NOVAST LABS (Feb 11, 2026)

Approval Letter NOVAST LABS (Feb 11, 2026)

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)