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 1141-1152 of 1819 letters

ALApproval Letter
Approval Letter GENENTECH (May 19, 2026)
FDA posted an approval letter for HERCEPTIN, HERCEPTIN HYLECTA on 2026-05-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 103792, BLA 761106 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 19, 2026
US FDA• HERCEPTIN / HERCEPTIN HYLECTA
ALApproval Letter
Approval Letter HIKMA PHARM CO LTD (May 19, 2026)
FDA posted an approval letter for ARGATROBAN on 2026-05-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203049 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 19, 2026
US FDA• ARGATROBAN
ALApproval Letter
Approval Letter DAIICHI SANKYO (May 19, 2026)
FDA posted an approval letter for ENHERTU on 2026-05-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761139 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 19, 2026
US FDA• ENHERTU
ALApproval Letter
Approval Letter IMPAX (May 19, 2026)
FDA posted an approval letter for CREXONT on 2026-05-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217186 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 19, 2026
US FDA• CREXONT
ALApproval Letter
Approval Letter GENENTECH INC (May 19, 2026)
FDA posted an approval letter for TECENTRIQ on 2026-05-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761034 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 19, 2026
US FDA• TECENTRIQ
ALApproval Letter
Approval Letter MDD US (May 19, 2026)
FDA posted an approval letter for ONAPGO on 2026-05-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214056 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 19, 2026
US FDA• ONAPGO
WLWarning Letter
Warning Letter vapetrinity.com (May 19, 2026)
FDA issued a warning letter to vapetrinity.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, 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.
IssuedMay 19, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter HealthPartners Neuroscience Center Research and Innovation (May 19, 2026)
FDA issued a warning letter to HealthPartners Neuroscience Center Research and Innovation concerning Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. Deterministic full-text screening identifies discussion of Data integrity and records, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 19, 2026
US FDA• Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
WLWarning Letter
Warning Letter snusguys.com (May 19, 2026)
FDA issued a warning letter to snusguys.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing, 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 19, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter npouches.com (May 19, 2026)
FDA issued a warning letter to npouches.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, 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.
IssuedMay 19, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter pouchline.com (May 19, 2026)
FDA issued a warning letter to pouchline.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing, 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 19, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter Skytron, LLC (May 19, 2026)
FDA issued a warning letter to Skytron, LLC concerning Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). 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.
IssuedMay 19, 2026
US FDA• Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)

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Approval Letter GENENTECH (May 19, 2026)

Approval Letter HIKMA PHARM CO LTD (May 19, 2026)

Approval Letter DAIICHI SANKYO (May 19, 2026)

Approval Letter IMPAX (May 19, 2026)

Approval Letter GENENTECH INC (May 19, 2026)

Approval Letter MDD US (May 19, 2026)

Warning Letter vapetrinity.com (May 19, 2026)

Warning Letter HealthPartners Neuroscience Center Research and Innovation (May 19, 2026)

Warning Letter snusguys.com (May 19, 2026)

Warning Letter npouches.com (May 19, 2026)

Warning Letter pouchline.com (May 19, 2026)

Warning Letter Skytron, LLC (May 19, 2026)