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 709-720 of 1819 letters

TATentative Approval Letter
Tentative Approval Letter APOTEX INC (Jul 22, 2026)
FDA posted a tentative approval letter for RUXOLITINIB on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 208869 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• RUXOLITINIB
ALApproval Letter
Approval Letter GLAXOSMITHKLINE (Jul 22, 2026)
FDA posted an approval letter for OJJAARA on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216873 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• OJJAARA
ALApproval Letter
Approval Letter MYLAN LABS LTD (Jul 22, 2026)
FDA posted an approval letter for FERRIC CARBOXYMALTOSE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 212572 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• FERRIC CARBOXYMALTOSE
ALApproval Letter
Approval Letter DR REDDYS (Jul 22, 2026)
FDA posted an approval letter for VENETOCLAX on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 214733 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• VENETOCLAX
ALApproval Letter
Approval Letter ALKEM LABS LTD (Jul 22, 2026)
FDA posted an approval letter for SOLRIAMFETOL HYDROCHLORIDE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218722 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• SOLRIAMFETOL HYDROCHLORIDE
TATentative Approval Letter
Tentative Approval Letter ZYDUS PHARMACEUTICALS (USA) INC. (Jul 22, 2026)
FDA posted a tentative approval letter for UBROGEPANT on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218662 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• UBROGEPANT
WLWarning Letter
Warning Letter Ohom Padmaavathii, LLC (Jul 22, 2026)
FDA issued a warning letter to Ohom Padmaavathii, LLC concerning Foreign Supplier Verification Program (FSVP). 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.
IssuedJul 22, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
TATentative Approval Letter
Tentative Approval Letter MSN LABORATORIES PRIVATE LIMITED (Jul 21, 2026)
FDA posted a tentative approval letter for UBROGEPANT on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219218 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 21, 2026
US FDA• UBROGEPANT
TATentative Approval Letter
Tentative Approval Letter ALEMBIC PHARMACEUTICALS LIMITED (Jul 21, 2026)
FDA posted a tentative approval letter for LAROTRECTINIB on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220639 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 21, 2026
US FDA• LAROTRECTINIB
TATentative Approval Letter
Tentative Approval Letter SANDOZ INC (Jul 21, 2026)
FDA posted a tentative approval letter for TIVOZANIB on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220437 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 21, 2026
US FDA• TIVOZANIB
TATentative Approval Letter
Tentative Approval Letter HETERO LABS LIMITED (Jul 21, 2026)
FDA posted a tentative approval letter for ANDA 220143 on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220143 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 21, 2026
US FDA• ANDA 220143
TATentative Approval Letter
Tentative Approval Letter REGCON HOLDINGS (Jul 21, 2026)
FDA posted a tentative approval letter for CEFTRIAXONE on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210197 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 21, 2026
US FDA• CEFTRIAXONE

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Tentative Approval Letter APOTEX INC (Jul 22, 2026)

Approval Letter GLAXOSMITHKLINE (Jul 22, 2026)

Approval Letter MYLAN LABS LTD (Jul 22, 2026)

Approval Letter DR REDDYS (Jul 22, 2026)

Approval Letter ALKEM LABS LTD (Jul 22, 2026)

Tentative Approval Letter ZYDUS PHARMACEUTICALS (USA) INC. (Jul 22, 2026)

Warning Letter Ohom Padmaavathii, LLC (Jul 22, 2026)

Tentative Approval Letter MSN LABORATORIES PRIVATE LIMITED (Jul 21, 2026)

Tentative Approval Letter ALEMBIC PHARMACEUTICALS LIMITED (Jul 21, 2026)

Tentative Approval Letter SANDOZ INC (Jul 21, 2026)

Tentative Approval Letter HETERO LABS LIMITED (Jul 21, 2026)

Tentative Approval Letter REGCON HOLDINGS (Jul 21, 2026)