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 889-900 of 1819 letters

ALApproval Letter
Approval Letter VISTAPHARM LLC (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 201194 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 KNOA PHARMA (Jun 23, 2026)
FDA posted an approval letter for BUTRANS on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021306 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• BUTRANS
ALApproval Letter
Approval Letter PROTEGA PHARMS (Jun 23, 2026)
FDA posted an approval letter for ROXYBOND on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209777 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• ROXYBOND
ALApproval Letter
Approval Letter COLLEGIUM PHARM INC (Jun 23, 2026)
FDA posted an approval letter for NUCYNTA ER on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 200533 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• NUCYNTA ER
ALApproval Letter
Approval Letter KNOA PHARMA (Jun 23, 2026)
FDA posted an approval letter for HYSINGLA ER on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206627 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• HYSINGLA ER
ALApproval Letter
Approval Letter KNOA PHARMA (Jun 23, 2026)
FDA posted an approval letter for OXYCONTIN on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022272 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• OXYCONTIN
ALApproval Letter
Approval Letter GENENTECH INC (Jun 23, 2026)
FDA posted an approval letter for LUNSUMIO, LUNSUMIO VELO on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761263 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• LUNSUMIO / LUNSUMIO VELO
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 202245 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 AGILE (Jun 23, 2026)
FDA posted an approval letter for TWIRLA on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204017 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 23, 2026
US FDA• TWIRLA
WLWarning Letter
Warning Letter LyfeUnit / www.lyfeunit.com (Jun 23, 2026)
FDA issued a warning letter to LyfeUnit / www.lyfeunit.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJun 23, 2026
US FDA• Unapproved New Drugs/Misbranded
WLWarning Letter
Warning Letter Ketamine Troche Store / www.ketaminetrochestore.com (Jun 23, 2026)
FDA issued a warning letter to Ketamine Troche Store / www.ketaminetrochestore.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJun 23, 2026
US FDA• Unapproved New Drugs/Misbranded
WLWarning Letter
Warning Letter Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com (Jun 23, 2026)
FDA issued a warning letter to Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJun 23, 2026
US FDA• Unapproved New Drugs/Misbranded

Page 75 of 152

1…73 74 75 76 77…152

Approval Letter VISTAPHARM LLC (Jun 23, 2026)

Approval Letter KNOA PHARMA (Jun 23, 2026)

Approval Letter PROTEGA PHARMS (Jun 23, 2026)

Approval Letter COLLEGIUM PHARM INC (Jun 23, 2026)

Approval Letter KNOA PHARMA (Jun 23, 2026)

Approval Letter KNOA PHARMA (Jun 23, 2026)

Approval Letter GENENTECH INC (Jun 23, 2026)

Approval Letter HIKMA (Jun 23, 2026)

Approval Letter AGILE (Jun 23, 2026)

Warning Letter LyfeUnit / www.lyfeunit.com (Jun 23, 2026)

Warning Letter Ketamine Troche Store / www.ketaminetrochestore.com (Jun 23, 2026)

Warning Letter Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com (Jun 23, 2026)