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 697-708 of 1819 letters

TATentative Approval Letter
Tentative Approval Letter AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD (Jul 22, 2026)
FDA posted a tentative approval letter for ANDA 220197 on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220197 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• ANDA 220197
ALApproval Letter
Approval Letter HIKMA (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 218016 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• SOLRIAMFETOL HYDROCHLORIDE
ALApproval Letter
Approval Letter ANNORA PHARMA (Jul 22, 2026)
FDA posted an approval letter for FOSTAMATINIB DISODIUM on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217329 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• FOSTAMATINIB DISODIUM
ALApproval Letter
Approval Letter LUPIN (Jul 22, 2026)
FDA posted an approval letter for SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 216095 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE
TATentative Approval Letter
Tentative Approval Letter MSN (Jul 22, 2026)
FDA posted a tentative approval letter for BOSUTINIB MONOHYDRATE, BOSUTINIB on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 209624 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• BOSUTINIB MONOHYDRATE / BOSUTINIB
ALApproval Letter
Approval Letter SANDOZ (Jul 22, 2026)
FDA posted an approval letter for VASOPRESSIN on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 212069 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• VASOPRESSIN
ALApproval Letter
Approval Letter AMNEAL (Jul 22, 2026)
FDA posted an approval letter for ROMIDEPSIN on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219099 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• ROMIDEPSIN
ALApproval Letter
Approval Letter PAI HOLDINGS (Jul 22, 2026)
FDA posted an approval letter for PROPRANOLOL HYDROCHLORIDE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219165 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• PROPRANOLOL HYDROCHLORIDE
TATentative Approval Letter
Tentative Approval Letter AFT PHARMACEUTICALS LTD (Jul 22, 2026)
FDA posted a tentative approval letter for SCOMARA on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218528 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• SCOMARA
ALApproval Letter
Approval Letter BRISTOL-MYERS (Jul 22, 2026)
FDA posted an approval letter for INREBIC on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212327 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• INREBIC
ALApproval Letter
Approval Letter SOBI (Jul 22, 2026)
FDA posted an approval letter for VONJO on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208712 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• VONJO
ALApproval Letter
Approval Letter MYLAN (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 217076 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• FERRIC CARBOXYMALTOSE

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Tentative Approval Letter AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD (Jul 22, 2026)

Approval Letter HIKMA (Jul 22, 2026)

Approval Letter ANNORA PHARMA (Jul 22, 2026)

Approval Letter LUPIN (Jul 22, 2026)

Tentative Approval Letter MSN (Jul 22, 2026)

Approval Letter SANDOZ (Jul 22, 2026)

Approval Letter AMNEAL (Jul 22, 2026)

Approval Letter PAI HOLDINGS (Jul 22, 2026)

Tentative Approval Letter AFT PHARMACEUTICALS LTD (Jul 22, 2026)

Approval Letter BRISTOL-MYERS (Jul 22, 2026)

Approval Letter SOBI (Jul 22, 2026)

Approval Letter MYLAN (Jul 22, 2026)