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 1765-1776 of 1819 letters

ALApproval Letter
Approval Letter BAUSCH AND LOMB (Jan 21, 2026)
FDA posted an approval letter for ZIRGAN on 2026-01-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022211 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 21, 2026
US FDA• ZIRGAN
ALApproval Letter
Approval Letter ALEMBIC (Jan 21, 2026)
FDA posted an approval letter for LOTEPREDNOL ETABONATE AND TOBRAMYCIN on 2026-01-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217597 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 21, 2026
US FDA• LOTEPREDNOL ETABONATE AND TOBRAMYCIN
ALApproval Letter
Approval Letter ELI LILLY AND CO (Jan 21, 2026)
FDA posted an approval letter for ZEPBOUND (AUTOINJECTOR), ZEPBOUND, ZEPBOUND KWIKPEN on 2026-01-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217806 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 21, 2026
US FDA• ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN
ALApproval Letter
Approval Letter ELI LILLY AND CO (Jan 21, 2026)
FDA posted an approval letter for MOUNJARO (AUTOINJECTOR), MOUNJARO, MOUNJARO KWIKPEN on 2026-01-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215866 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 21, 2026
US FDA• MOUNJARO (AUTOINJECTOR) / MOUNJARO / MOUNJARO KWIKPEN
WLWarning Letter
Warning Letter Supersmart USA, LLC (Jan 21, 2026)
FDA issued a warning letter to Supersmart USA, LLC concerning New Drug/Misbranded. Deterministic full-text screening identifies discussion of 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.
IssuedJan 21, 2026
US FDA• New Drug/Misbranded
WLWarning Letter
Warning Letter Signature Formulations, LLC (Jan 21, 2026)
FDA issued a warning letter to Signature Formulations, LLC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, 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.
IssuedJan 21, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Naumes, Inc. (Jan 21, 2026)
FDA issued a warning letter to Naumes, Inc. concerning Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.
IssuedJan 21, 2026
US FDA• Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated
ALApproval Letter
Approval Letter TEVA PHARMS INC (Jan 20, 2026)
FDA posted an approval letter for ALVAIZ on 2026-01-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216774 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 20, 2026
US FDA• ALVAIZ
ALApproval Letter
Approval Letter FRESENIUS KABI USA (Jan 20, 2026)
FDA posted an approval letter for OTULFI on 2026-01-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761379 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 20, 2026
US FDA• OTULFI
ALApproval Letter
Approval Letter ACCORD BIOPHARMA INC. (Jan 20, 2026)
FDA posted an approval letter for FILKRI on 2026-01-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761027 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 20, 2026
US FDA• FILKRI
ALApproval Letter
Approval Letter BIONPHARMA (Jan 20, 2026)
FDA posted an approval letter for NAPROXEN SODIUM on 2026-01-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021920 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 20, 2026
US FDA• NAPROXEN SODIUM
WLWarning Letter
Warning Letter GenoGenix LLC (Jan 20, 2026)
FDA issued a warning letter to GenoGenix LLC concerning Compounding Pharmacy/Adulterated Drug Products. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJan 20, 2026
US FDA• Compounding Pharmacy/Adulterated Drug Products

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Approval Letter BAUSCH AND LOMB (Jan 21, 2026)

Approval Letter ALEMBIC (Jan 21, 2026)

Approval Letter ELI LILLY AND CO (Jan 21, 2026)

Approval Letter ELI LILLY AND CO (Jan 21, 2026)

Warning Letter Supersmart USA, LLC (Jan 21, 2026)

Warning Letter Signature Formulations, LLC (Jan 21, 2026)

Warning Letter Naumes, Inc. (Jan 21, 2026)

Approval Letter TEVA PHARMS INC (Jan 20, 2026)

Approval Letter FRESENIUS KABI USA (Jan 20, 2026)

Approval Letter ACCORD BIOPHARMA INC. (Jan 20, 2026)

Approval Letter BIONPHARMA (Jan 20, 2026)

Warning Letter GenoGenix LLC (Jan 20, 2026)