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 877-888 of 1819 letters

ALApproval Letter
Approval Letter ZYLA (Jun 23, 2026)
FDA posted an approval letter for OXAYDO on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202080 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• OXAYDO
ALApproval Letter
Approval Letter CIPHER PHARMS INC (Jun 23, 2026)
FDA posted an approval letter for CONZIP on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022370 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• CONZIP
ALApproval Letter
Approval Letter ROSEMOUNT (Jun 23, 2026)
FDA posted an approval letter for QDOLO on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214044 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• QDOLO
ALApproval Letter
Approval Letter AGIOS PHARMS INC (Jun 23, 2026)
FDA posted an approval letter for PYRUKYND, AQVESME on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216196 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• PYRUKYND / AQVESME
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 200534 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 ENDO OPERATIONS (Jun 23, 2026)
FDA posted an approval letter for PERCODAN-DEMI, PERCODAN on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 007337 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• PERCODAN-DEMI / PERCODAN
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 022195 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• MORPHINE SULFATE
ALApproval Letter
Approval Letter BDSI (Jun 23, 2026)
FDA posted an approval letter for BELBUCA on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207932 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• BELBUCA
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 022304 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 HIKMA (Jun 23, 2026)
FDA posted an approval letter for CODEINE SULFATE on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022402 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• CODEINE SULFATE
ALApproval Letter
Approval Letter QUAGEN (Jun 23, 2026)
FDA posted an approval letter for DEMEROL on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 005010 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• DEMEROL
ALApproval Letter
Approval Letter SPECGX LLC (Jun 23, 2026)
FDA posted an approval letter for ROXICODONE on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021011 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• ROXICODONE

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Approval Letter ZYLA (Jun 23, 2026)

Approval Letter CIPHER PHARMS INC (Jun 23, 2026)

Approval Letter ROSEMOUNT (Jun 23, 2026)

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)