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 1105-1116 of 1819 letters

ALApproval Letter
Approval Letter BIOGEN MA (May 27, 2026)
FDA posted an approval letter for TOFIDENCE on 2026-05-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761354 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 27, 2026
US FDA• TOFIDENCE
ALApproval Letter
Approval Letter ACTELION (May 27, 2026)
FDA posted an approval letter for UPTRAVI on 2026-05-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207947, NDA 214275 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 27, 2026
US FDA• UPTRAVI
WLWarning Letter
Warning Letter Pharmathen International S.A. (May 27, 2026)
FDA issued a warning letter to Pharmathen International S.A. concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 27, 2026
US FDA• CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
WLWarning Letter
Warning Letter Linemaster Switch Corporation (May 27, 2026)
FDA issued a warning letter to Linemaster Switch Corporation concerning CGMP/QSR/Drug/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 27, 2026
US FDA• CGMP/QSR/Drug/Medical Devices/Adulterated
ALApproval Letter
Approval Letter ABBVIE (May 26, 2026)
FDA posted an approval letter for VENCLEXTA on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208573 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 26, 2026
US FDA• VENCLEXTA
ALApproval Letter
Approval Letter ABBVIE (May 26, 2026)
FDA posted an approval letter for LINZESS on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202811 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 26, 2026
US FDA• LINZESS
ALApproval Letter
Approval Letter HOSPIRA INC (May 26, 2026)
FDA posted an approval letter for NYVEPRIA on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761111 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 26, 2026
US FDA• NYVEPRIA
TATentative Approval Letter
Tentative Approval Letter RENATA LIMITED (May 26, 2026)
FDA posted a tentative approval letter for ANDA 219257 on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219257 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 26, 2026
US FDA• ANDA 219257
ALApproval Letter
Approval Letter APOTEX (May 26, 2026)
FDA posted an approval letter for CANAGLIFLOZIN on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210449 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 26, 2026
US FDA• CANAGLIFLOZIN
ALApproval Letter
Approval Letter RUBICON RESEARCH (May 26, 2026)
FDA posted an approval letter for CLONAZEPAM on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 216988 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 26, 2026
US FDA• CLONAZEPAM
ALApproval Letter
Approval Letter BOSTON SCITFC (May 26, 2026)
FDA posted an approval letter for VARITHENA on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205098 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 26, 2026
US FDA• VARITHENA
ALApproval Letter
Approval Letter NATCO (May 26, 2026)
FDA posted an approval letter for THALIDOMIDE on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 213267 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 26, 2026
US FDA• THALIDOMIDE

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Approval Letter BIOGEN MA (May 27, 2026)

Approval Letter ACTELION (May 27, 2026)

Warning Letter Pharmathen International S.A. (May 27, 2026)

Warning Letter Linemaster Switch Corporation (May 27, 2026)

Approval Letter ABBVIE (May 26, 2026)

Approval Letter ABBVIE (May 26, 2026)

Approval Letter HOSPIRA INC (May 26, 2026)

Tentative Approval Letter RENATA LIMITED (May 26, 2026)

Approval Letter APOTEX (May 26, 2026)

Approval Letter RUBICON RESEARCH (May 26, 2026)

Approval Letter BOSTON SCITFC (May 26, 2026)

Approval Letter NATCO (May 26, 2026)