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 1801-1812 of 1819 letters

ALApproval Letter
Approval Letter TEVA PHARMS USA INC (Jan 13, 2026)
FDA posted an approval letter for ESTRADIOL on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 214137 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 13, 2026
US FDA• ESTRADIOL
ALApproval Letter
Approval Letter AMNEAL IRELAND LTD (Jan 13, 2026)
FDA posted an approval letter for BECLOMETHASONE DIPROPIONATE on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 213811 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 13, 2026
US FDA• BECLOMETHASONE DIPROPIONATE
TATentative Approval Letter
Tentative Approval Letter APOTEX CORP (Jan 13, 2026)
FDA posted a tentative approval letter for RIMEGEPANT on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219399 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 13, 2026
US FDA• RIMEGEPANT
ALApproval Letter
Approval Letter SENTYNL THERAPS INC (Jan 13, 2026)
FDA posted an approval letter for ZYCUBO on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211241 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 13, 2026
US FDA• ZYCUBO
WLWarning Letter
Warning Letter Center For Immunology Science, LLC (Jan 13, 2026)
FDA issued a warning letter to Center For Immunology Science, LLC concerning Sponsor/Investigator. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Unapproved products and premarket authorization, Quality systems and CAPA, 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.
IssuedJan 13, 2026
US FDA• Sponsor/Investigator
ALApproval Letter
Approval Letter XCOVERY (Jan 9, 2026)
FDA posted an approval letter for ENSACOVE on 2026-01-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218171 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 9, 2026
US FDA• ENSACOVE
WLWarning Letter
Warning Letter CC Pollen Company (Jan 9, 2026)
FDA issued a warning letter to CC Pollen Company concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJan 9, 2026
US FDA• CGMP/Dietary Supplement/Adulterated/Misbranded
WLWarning Letter
Warning Letter Germaphobix (Jan 9, 2026)
FDA issued a warning letter to Germaphobix concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, 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.
IssuedJan 9, 2026
US FDA• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
WLWarning Letter
Warning Letter Christopher Dale Butler (Jan 9, 2026)
FDA issued a warning letter to Christopher Dale Butler concerning Acidified Foods/Emergency Permit Control/Adulterated. 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.
IssuedJan 9, 2026
US FDA• Acidified Foods/Emergency Permit Control/Adulterated
ALApproval Letter
Approval Letter ELI LILLY AND CO (Jan 8, 2026)
FDA posted an approval letter for ZEPBOUND (AUTOINJECTOR), ZEPBOUND, ZEPBOUND KWIKPEN on 2026-01-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217806 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 8, 2026
US FDA• ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN
ALApproval Letter
Approval Letter SAREPTA THERAPS INC (Jan 8, 2026)
FDA posted an approval letter for AMONDYS 45 on 2026-01-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213026 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 8, 2026
US FDA• AMONDYS 45
ALApproval Letter
Approval Letter BIOCON BIOLOGICS INC (Jan 8, 2026)
FDA posted an approval letter for YESINTEK on 2026-01-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761406 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 8, 2026
US FDA• YESINTEK

Page 151 of 152

1…149 150 151 152

Approval Letter TEVA PHARMS USA INC (Jan 13, 2026)

Approval Letter AMNEAL IRELAND LTD (Jan 13, 2026)

Tentative Approval Letter APOTEX CORP (Jan 13, 2026)

Approval Letter SENTYNL THERAPS INC (Jan 13, 2026)

Warning Letter Center For Immunology Science, LLC (Jan 13, 2026)

Approval Letter XCOVERY (Jan 9, 2026)

Warning Letter CC Pollen Company (Jan 9, 2026)

Warning Letter Germaphobix (Jan 9, 2026)

Warning Letter Christopher Dale Butler (Jan 9, 2026)

Approval Letter ELI LILLY AND CO (Jan 8, 2026)

Approval Letter SAREPTA THERAPS INC (Jan 8, 2026)

Approval Letter BIOCON BIOLOGICS INC (Jan 8, 2026)