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 565-576 of 1503 letters

ALApproval Letter
Approval Letter AGIOS PHARMS INC (Jun 23, 2026)
FDA issued an approval letter for PYRUKYND, AQVESME on 2026-06-23. The source metadata identifies NDA 216196 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• PYRUKYND / AQVESME
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 200534 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 ENDO OPERATIONS (Jun 23, 2026)
FDA issued an approval letter for PERCODAN-DEMI, PERCODAN on 2026-06-23. The source metadata identifies NDA 007337 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• PERCODAN-DEMI / PERCODAN
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 022195 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 BDSI (Jun 23, 2026)
FDA issued an approval letter for BELBUCA on 2026-06-23. The source metadata identifies NDA 207932 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• BELBUCA
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 022304 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• NUCYNTA
ALApproval Letter
Approval Letter HIKMA (Jun 23, 2026)
FDA issued an approval letter for CODEINE SULFATE on 2026-06-23. The source metadata identifies NDA 022402 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• CODEINE SULFATE
ALApproval Letter
Approval Letter QUAGEN (Jun 23, 2026)
FDA issued an approval letter for DEMEROL on 2026-06-23. The source metadata identifies NDA 005010 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• DEMEROL
ALApproval Letter
Approval Letter SPECGX LLC (Jun 23, 2026)
FDA issued an approval letter for ROXICODONE on 2026-06-23. The source metadata identifies NDA 021011 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• ROXICODONE
ALApproval Letter
Approval Letter VISTAPHARM LLC (Jun 23, 2026)
FDA issued an approval letter for OXYCODONE HYDROCHLORIDE on 2026-06-23. The source metadata identifies NDA 201194 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 KNOA PHARMA (Jun 23, 2026)
FDA issued an approval letter for BUTRANS on 2026-06-23. The source metadata identifies NDA 021306 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• BUTRANS
ALApproval Letter
Approval Letter PROTEGA PHARMS (Jun 23, 2026)
FDA issued an approval letter for ROXYBOND on 2026-06-23. The source metadata identifies NDA 209777 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• ROXYBOND

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Approval Letter AGIOS PHARMS INC (Jun 23, 2026)

Approval Letter GENUS LIFESCIENCES (Jun 23, 2026)

Approval Letter ENDO OPERATIONS (Jun 23, 2026)

Approval Letter HIKMA (Jun 23, 2026)

Approval Letter BDSI (Jun 23, 2026)

Approval Letter COLLEGIUM PHARM INC (Jun 23, 2026)

Approval Letter HIKMA (Jun 23, 2026)

Approval Letter QUAGEN (Jun 23, 2026)

Approval Letter SPECGX LLC (Jun 23, 2026)

Approval Letter VISTAPHARM LLC (Jun 23, 2026)

Approval Letter KNOA PHARMA (Jun 23, 2026)

Approval Letter PROTEGA PHARMS (Jun 23, 2026)