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 1261-1272 of 1819 letters

ALApproval Letter
Approval Letter TAKEDA PHARMS USA (Apr 27, 2026)
FDA posted an approval letter for ADDERALL XR 10, ADDERALL XR 20, ADDERALL XR 30 on 2026-04-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021303, NDA 021977, NDA 022063, NDA 208510 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 27, 2026
US FDA• ADDERALL XR 10 / ADDERALL XR 20 / ADDERALL XR 30
ALApproval Letter
Approval Letter B BRAUN (Apr 27, 2026)
FDA posted an approval letter for METRO I.V. IN PLASTIC CONTAINER on 2026-04-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 018900 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 27, 2026
US FDA• METRO I.V. IN PLASTIC CONTAINER
ALApproval Letter
Approval Letter ASTRAZENECA AB (Apr 27, 2026)
FDA posted an approval letter for SAPHNELO on 2026-04-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761451 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 27, 2026
US FDA• SAPHNELO
ALApproval Letter
Approval Letter INTRA-CELLULAR (Apr 27, 2026)
FDA posted an approval letter for CAPLYTA on 2026-04-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209500 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 27, 2026
US FDA• CAPLYTA
ALApproval Letter
Approval Letter BAYER HEALTHCARE LLC (Apr 27, 2026)
FDA posted an approval letter for CHILDREN'S CLARITIN, CLARITIN on 2026-04-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021891 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 27, 2026
US FDA• CHILDREN'S CLARITIN / CLARITIN
ALApproval Letter
Approval Letter REGENERON PHARMACEUTICALS (Apr 24, 2026)
FDA posted an approval letter for DUPIXENT on 2026-04-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761055 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 24, 2026
US FDA• DUPIXENT
ALApproval Letter
Approval Letter RENEW PHARMS (Apr 24, 2026)
FDA posted an approval letter for IC-GREEN on 2026-04-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 011525 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 24, 2026
US FDA• IC-GREEN
WLWarning Letter
Warning Letter Greenworld Food Express LLC (Apr 24, 2026)
FDA issued a warning letter to Greenworld Food Express LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedApr 24, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter vibepixi.com (Apr 24, 2026)
FDA issued a warning letter to vibepixi.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Tobacco product authorization and marketing, 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.
IssuedApr 24, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter Ray’s Vitamins (Apr 24, 2026)
FDA issued a warning letter to Ray’s Vitamins concerning Unapproved New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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.
IssuedApr 24, 2026
US FDA• Unapproved New Drug/Misbranded
WLWarning Letter
Warning Letter ibeautistore.com (Apr 24, 2026)
FDA issued a warning letter to ibeautistore.com concerning Unapproved New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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.
IssuedApr 24, 2026
US FDA• Unapproved New Drug/Misbranded
WLWarning Letter
Warning Letter Great One Trading Inc. (Apr 24, 2026)
FDA issued a warning letter to Great One Trading Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedApr 24, 2026
US FDA• Foreign Supplier Verification Program (FSVP)

Page 106 of 152

1…104 105 106 107 108…152

Approval Letter TAKEDA PHARMS USA (Apr 27, 2026)

Approval Letter B BRAUN (Apr 27, 2026)

Approval Letter ASTRAZENECA AB (Apr 27, 2026)

Approval Letter INTRA-CELLULAR (Apr 27, 2026)

Approval Letter BAYER HEALTHCARE LLC (Apr 27, 2026)

Approval Letter REGENERON PHARMACEUTICALS (Apr 24, 2026)

Approval Letter RENEW PHARMS (Apr 24, 2026)

Warning Letter Greenworld Food Express LLC (Apr 24, 2026)

Warning Letter vibepixi.com (Apr 24, 2026)

Warning Letter Ray’s Vitamins (Apr 24, 2026)

Warning Letter ibeautistore.com (Apr 24, 2026)

Warning Letter Great One Trading Inc. (Apr 24, 2026)