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 1,503 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 685-696 of 1503 letters

TATentative Approval Letter
Tentative Approval Letter APPCO PHARMA LLC (Jun 8, 2026)
FDA issued a tentative approval letter for VILOXAZINE HYDROCHLORIDE on 2026-06-08. The source metadata identifies ANDA 220326 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 8, 2026
US FDA• VILOXAZINE HYDROCHLORIDE
TATentative Approval Letter
Tentative Approval Letter CHANGZHOU PHARMACEUTICAL FACTORY (Jun 8, 2026)
FDA issued a tentative approval letter for VERICIGUAT on 2026-06-08. The source metadata identifies ANDA 220264 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 8, 2026
US FDA• VERICIGUAT
TATentative Approval Letter
Tentative Approval Letter TORRENT PHARMACEUTICALS LTD (Jun 8, 2026)
FDA issued a tentative approval letter for VERICIGUAT on 2026-06-08. The source metadata identifies ANDA 220221 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 8, 2026
US FDA• VERICIGUAT
TATentative Approval Letter
Tentative Approval Letter ANNORA PHARMA PRIVATE LIMITED (Jun 8, 2026)
FDA issued a tentative approval letter for GABAPENTIN ENACARBIL on 2026-06-08. The source metadata identifies ANDA 220420 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 8, 2026
US FDA• GABAPENTIN ENACARBIL
TATentative Approval Letter
Tentative Approval Letter ALKEM LABORATORIES LIMITED (Jun 8, 2026)
FDA issued a tentative approval letter for ANDA 220352 on 2026-06-08. The source metadata identifies ANDA 220352 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 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 source-metadata 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 source-metadata 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)
WLWarning Letter
Warning Letter Momentum Health 360 dba Momentum Health (Jun 8, 2026)
FDA issued a warning letter to Momentum Health 360 dba Momentum Health concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic source-metadata 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 Ezra Holdco LLC dba Ezra (Jun 8, 2026)
FDA issued a warning letter to Ezra Holdco LLC dba Ezra 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 Nova Vascular LLC dba NOVARX (Jun 8, 2026)
FDA issued a warning letter to Nova Vascular LLC dba NOVARX 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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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)

Warning Letter Momentum Health 360 dba Momentum Health (Jun 8, 2026)

Warning Letter Ezra Holdco LLC dba Ezra (Jun 8, 2026)

Warning Letter Nova Vascular LLC dba NOVARX (Jun 8, 2026)