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 865-876 of 1819 letters

ALApproval Letter
Approval Letter COLLEGIUM PHARM INC (Jun 23, 2026)
FDA posted an approval letter for XTAMPZA ER on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208090 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• XTAMPZA ER
ALApproval Letter
Approval Letter ZEALAND PHARMA (Jun 23, 2026)
FDA posted an approval letter for ZEGALOGUE, ZEGALOGUE (AUTOINJECTOR) on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214231 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• ZEGALOGUE / ZEGALOGUE (AUTOINJECTOR)
ALApproval Letter
Approval Letter KNOA PHARMA (Jun 23, 2026)
FDA posted an approval letter for MS CONTIN on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019516 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• MS CONTIN
ALApproval Letter
Approval Letter COLLEGIUM PHARM INC (Jun 23, 2026)
FDA posted an approval letter for NUCYNTA on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203794 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• NUCYNTA
ALApproval Letter
Approval Letter RHODES PHARMS (Jun 23, 2026)
FDA posted an approval letter for DILAUDID on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019891, NDA 019892 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• DILAUDID
ALApproval Letter
Approval Letter LAVIPHARM (Jun 23, 2026)
FDA posted an approval letter for CATAPRES-TTS-1, CATAPRES-TTS-2, CATAPRES-TTS-3 on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 018891 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• CATAPRES-TTS-1 / CATAPRES-TTS-2 / CATAPRES-TTS-3
ALApproval Letter
Approval Letter ACTAVIS LABS UT INC (Jun 23, 2026)
FDA posted an approval letter for FIORICET W/ CODEINE on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020232 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• FIORICET W/ CODEINE
ALApproval Letter
Approval Letter BRACCO (Jun 23, 2026)
FDA posted an approval letter for ISOVUE-M 200, ISOVUE-300, ISOVUE-370 on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 018735, NDA 020327 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• ISOVUE-M 200 / ISOVUE-300 / ISOVUE-370
ALApproval Letter
Approval Letter GENUS LIFESCIENCES (Jun 23, 2026)
FDA posted an approval letter for OXYCODONE HYDROCHLORIDE on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 200535 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• OXYCODONE HYDROCHLORIDE
ALApproval Letter
Approval Letter PHOTOCURE ASA (Jun 23, 2026)
FDA posted an approval letter for CYSVIEW KIT on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022555 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• CYSVIEW KIT
ALApproval Letter
Approval Letter SUN PHARM INDUSTRIES (Jun 23, 2026)
FDA posted an approval letter for SYNALGOS-DC on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 011483 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• SYNALGOS-DC
ALApproval Letter
Approval Letter HIKMA (Jun 23, 2026)
FDA posted an approval letter for MORPHINE SULFATE on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022207 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• MORPHINE SULFATE

Page 73 of 152

1…71 72 73 74 75…152

Approval Letter COLLEGIUM PHARM INC (Jun 23, 2026)

Approval Letter ZEALAND PHARMA (Jun 23, 2026)

Approval Letter KNOA PHARMA (Jun 23, 2026)

Approval Letter COLLEGIUM PHARM INC (Jun 23, 2026)

Approval Letter RHODES PHARMS (Jun 23, 2026)

Approval Letter LAVIPHARM (Jun 23, 2026)

Approval Letter ACTAVIS LABS UT INC (Jun 23, 2026)

Approval Letter BRACCO (Jun 23, 2026)

Approval Letter GENUS LIFESCIENCES (Jun 23, 2026)

Approval Letter PHOTOCURE ASA (Jun 23, 2026)

Approval Letter SUN PHARM INDUSTRIES (Jun 23, 2026)

Approval Letter HIKMA (Jun 23, 2026)