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 1213-1224 of 1503 letters

ALApproval Letter
Approval Letter PF PRISM CV (Mar 4, 2026)
FDA issued an approval letter for BOSULIF on 2026-03-04. The source metadata identifies NDA 217729 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 4, 2026
US FDA• BOSULIF
ALApproval Letter
Approval Letter ARRAY BIOPHARMA INC (Mar 4, 2026)
FDA issued an approval letter for BRAFTOVI on 2026-03-04. The source metadata identifies NDA 210496 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 4, 2026
US FDA• BRAFTOVI
ALApproval Letter
Approval Letter ACTELION (Mar 4, 2026)
FDA issued an approval letter for TRACLEER on 2026-03-04. The source metadata identifies NDA 021290, NDA 209279 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 4, 2026
US FDA• TRACLEER
ALApproval Letter
Approval Letter ORGANON USA LLC (Mar 4, 2026)
FDA issued an approval letter for FOLLISTIM AQ on 2026-03-04. The source metadata identifies BLA 021211 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 4, 2026
US FDA• FOLLISTIM AQ
ALApproval Letter
Approval Letter HIKMA (Mar 4, 2026)
FDA issued an approval letter for ROBINUL on 2026-03-04. The source metadata identifies NDA 017558 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 4, 2026
US FDA• ROBINUL
WLWarning Letter
Warning Letter Citra100mg (Mar 4, 2026)
FDA issued a warning letter to Citra100mg concerning Unapproved New Drugs/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.
IssuedMar 4, 2026
US FDA• Unapproved New Drugs/Misbranded
ALApproval Letter
Approval Letter EUGIA PHARMA SPECLTS (Mar 3, 2026)
FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 202668, ANDA 202669 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• FLUOROURACIL
ALApproval Letter
Approval Letter SAGENT PHARMS INC (Mar 3, 2026)
FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 203608, ANDA 203609 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• FLUOROURACIL
ALApproval Letter
Approval Letter ALEMBIC (Mar 3, 2026)
FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 217295, ANDA 217676 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• FLUOROURACIL
ALApproval Letter
Approval Letter FRESENIUS KABI USA (Mar 3, 2026)
FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 040278, ANDA 040279 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• FLUOROURACIL
ALApproval Letter
Approval Letter NOVO NORDISK INC (Mar 3, 2026)
FDA issued an approval letter for SOGROYA on 2026-03-03. The source metadata identifies BLA 761156 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• SOGROYA
ALApproval Letter
Approval Letter MACLEODS PHARMS LTD (Mar 3, 2026)
FDA issued an approval letter for DILTIAZEM HYDROCHLORIDE on 2026-03-03. The source metadata identifies ANDA 218744 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• DILTIAZEM HYDROCHLORIDE

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Approval Letter PF PRISM CV (Mar 4, 2026)

Approval Letter ARRAY BIOPHARMA INC (Mar 4, 2026)

Approval Letter ACTELION (Mar 4, 2026)

Approval Letter ORGANON USA LLC (Mar 4, 2026)

Approval Letter HIKMA (Mar 4, 2026)

Warning Letter Citra100mg (Mar 4, 2026)

Approval Letter EUGIA PHARMA SPECLTS (Mar 3, 2026)

Approval Letter SAGENT PHARMS INC (Mar 3, 2026)

Approval Letter ALEMBIC (Mar 3, 2026)

Approval Letter FRESENIUS KABI USA (Mar 3, 2026)

Approval Letter NOVO NORDISK INC (Mar 3, 2026)

Approval Letter MACLEODS PHARMS LTD (Mar 3, 2026)