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 997-1008 of 1819 letters

ALApproval Letter
Approval Letter AUROBINDO PHARMA LTD (Jun 8, 2026)
FDA posted an approval letter for TOFACITINIB CITRATE on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 215356 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 8, 2026
US FDA• TOFACITINIB CITRATE
ALApproval Letter
Approval Letter SAGENT (Jun 8, 2026)
FDA posted an approval letter for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220483 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 8, 2026
US FDA• NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
ALApproval Letter
Approval Letter CHATTEM SANOFI (Jun 8, 2026)
FDA posted an approval letter for CHILDREN'S ALLEGRA ALLERGY, CHILDREN'S ALLEGRA HIVES on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021909 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 8, 2026
US FDA• CHILDREN'S ALLEGRA ALLERGY / CHILDREN'S ALLEGRA HIVES
TATentative Approval Letter
Tentative Approval Letter APPCO PHARMA LLC (Jun 8, 2026)
FDA posted a tentative approval letter for VILOXAZINE HYDROCHLORIDE on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220326 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 8, 2026
US FDA• VILOXAZINE HYDROCHLORIDE
TATentative Approval Letter
Tentative Approval Letter CHANGZHOU PHARMACEUTICAL FACTORY (Jun 8, 2026)
FDA posted a tentative approval letter for VERICIGUAT on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220264 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 8, 2026
US FDA• VERICIGUAT
TATentative Approval Letter
Tentative Approval Letter TORRENT PHARMACEUTICALS LTD (Jun 8, 2026)
FDA posted a tentative approval letter for VERICIGUAT on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220221 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 8, 2026
US FDA• VERICIGUAT
TATentative Approval Letter
Tentative Approval Letter ANNORA PHARMA PRIVATE LIMITED (Jun 8, 2026)
FDA posted a tentative approval letter for GABAPENTIN ENACARBIL on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220420 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 8, 2026
US FDA• GABAPENTIN ENACARBIL
TATentative Approval Letter
Tentative Approval Letter ALKEM LABORATORIES LIMITED (Jun 8, 2026)
FDA posted a tentative approval letter for ANDA 220352 on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220352 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 8, 2026
US FDA• ANDA 220352
WLWarning Letter
Warning Letter Maximus Health, Inc. dba Maximus (Jun 8, 2026)
FDA issued a warning letter to Maximus Health, Inc. dba Maximus concerning False & Misleading Claims/Misbranded (Telehealth). 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.
IssuedJun 8, 2026
US FDA• False & Misleading Claims/Misbranded (Telehealth)
WLWarning Letter
Warning Letter Medica Weight Loss (Jun 8, 2026)
FDA issued a warning letter to Medica Weight Loss concerning False & Misleading Claims/Misbranded (Telehealth). 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.
IssuedJun 8, 2026
US FDA• False & Misleading Claims/Misbranded (Telehealth)
WLWarning Letter
Warning Letter HydraMed IV LLC dba HydraMed (Jun 8, 2026)
FDA issued a warning letter to HydraMed IV LLC dba HydraMed concerning False & Misleading Claims/Misbranded (Telehealth). 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.
IssuedJun 8, 2026
US FDA• False & Misleading Claims/Misbranded (Telehealth)
WLWarning Letter
Warning Letter FITISH (Jun 8, 2026)
FDA issued a warning letter to FITISH concerning False & Misleading Claims/Misbranded (Telehealth). 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.
IssuedJun 8, 2026
US FDA• False & Misleading Claims/Misbranded (Telehealth)

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Approval Letter AUROBINDO PHARMA LTD (Jun 8, 2026)

Approval Letter SAGENT (Jun 8, 2026)

Approval Letter CHATTEM SANOFI (Jun 8, 2026)

Tentative Approval Letter APPCO PHARMA LLC (Jun 8, 2026)

Tentative Approval Letter CHANGZHOU PHARMACEUTICAL FACTORY (Jun 8, 2026)

Tentative Approval Letter TORRENT PHARMACEUTICALS LTD (Jun 8, 2026)

Tentative Approval Letter ANNORA PHARMA PRIVATE LIMITED (Jun 8, 2026)

Tentative Approval Letter ALKEM LABORATORIES LIMITED (Jun 8, 2026)

Warning Letter Maximus Health, Inc. dba Maximus (Jun 8, 2026)

Warning Letter Medica Weight Loss (Jun 8, 2026)

Warning Letter HydraMed IV LLC dba HydraMed (Jun 8, 2026)

Warning Letter FITISH (Jun 8, 2026)