Source facts
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.
US FDA source recordAL · Approval Letter
DILAUDID — FDA Approval Letter (NDA 019891)
Issued to RHODES PHARMS. Application is approved as submitted.
Issued
June 23, 2026Application
NDA 505b1 • 019891
Product
DILAUDID
Company
RHODES PHARMS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for DILAUDID?
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Key details in this letter
- 1FDA action: approval.
- 2Applications: NDA 019891, NDA 019892.
- 3Submission: supplement.
- 4Sponsor: RHODES PHARMS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the DILAUDID approval letter
Is DILAUDID FDA approved?
This letter documents an FDA approval action: FDA approved NDA 019891 for DILAUDID, sponsored by RHODES PHARMS, on June 23, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 019891?
NDA 019891 is the application under which FDA issued this approval letter for DILAUDID to RHODES PHARMS. The letter is dated June 23, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.