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 553-564 of 1503 letters

ALApproval Letter
Approval Letter COLLEGIUM PHARM INC (Jun 23, 2026)
FDA issued an approval letter for NUCYNTA on 2026-06-23. The source metadata identifies NDA 203794 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• NUCYNTA
ALApproval Letter
Approval Letter RHODES PHARMS (Jun 23, 2026)
FDA issued an approval letter for DILAUDID on 2026-06-23. The source metadata identifies NDA 019891, NDA 019892 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• DILAUDID
ALApproval Letter
Approval Letter LAVIPHARM (Jun 23, 2026)
FDA issued an approval letter for CATAPRES-TTS-1, CATAPRES-TTS-2, CATAPRES-TTS-3 on 2026-06-23. The source metadata identifies NDA 018891 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 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 issued an approval letter for FIORICET W/ CODEINE on 2026-06-23. The source metadata identifies NDA 020232 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• FIORICET W/ CODEINE
ALApproval Letter
Approval Letter BRACCO (Jun 23, 2026)
FDA issued an approval letter for ISOVUE-M 200, ISOVUE-300, ISOVUE-370 on 2026-06-23. The source metadata identifies NDA 018735, NDA 020327 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• ISOVUE-M 200 / ISOVUE-300 / ISOVUE-370
ALApproval Letter
Approval Letter GENUS LIFESCIENCES (Jun 23, 2026)
FDA issued an approval letter for OXYCODONE HYDROCHLORIDE on 2026-06-23. The source metadata identifies NDA 200535 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• OXYCODONE HYDROCHLORIDE
ALApproval Letter
Approval Letter PHOTOCURE ASA (Jun 23, 2026)
FDA issued an approval letter for CYSVIEW KIT on 2026-06-23. The source metadata identifies NDA 022555 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• CYSVIEW KIT
ALApproval Letter
Approval Letter SUN PHARM INDUSTRIES (Jun 23, 2026)
FDA issued an approval letter for SYNALGOS-DC on 2026-06-23. The source metadata identifies NDA 011483 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• SYNALGOS-DC
ALApproval Letter
Approval Letter HIKMA (Jun 23, 2026)
FDA issued an approval letter for MORPHINE SULFATE on 2026-06-23. The source metadata identifies NDA 022207 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• MORPHINE SULFATE
ALApproval Letter
Approval Letter ZYLA (Jun 23, 2026)
FDA issued an approval letter for OXAYDO on 2026-06-23. The source metadata identifies NDA 202080 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• OXAYDO
ALApproval Letter
Approval Letter CIPHER PHARMS INC (Jun 23, 2026)
FDA issued an approval letter for CONZIP on 2026-06-23. The source metadata identifies NDA 022370 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• CONZIP
ALApproval Letter
Approval Letter ROSEMONT (Jun 23, 2026)
FDA issued an approval letter for QDOLO on 2026-06-23. The source metadata identifies NDA 214044 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• QDOLO

Page 47 of 126

1…45 46 47 48 49…126

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)

Approval Letter ZYLA (Jun 23, 2026)

Approval Letter CIPHER PHARMS INC (Jun 23, 2026)

Approval Letter ROSEMONT (Jun 23, 2026)