Source facts
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.
US FDA source recordAL · Approval Letter
MORPHINE SULFATE — FDA Approval Letter (NDA 022207)
Issued to HIKMA. Application is approved as submitted.
Issued
June 23, 2026Application
NDA 505b1 • 022207
Product
MORPHINE SULFATE
Company
HIKMA
Stage
Final Decision
Assyro regulatory brief
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 022207.
- 3Submission: supplement.
- 4Sponsor: HIKMA.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the MORPHINE SULFATE approval letter
Is MORPHINE SULFATE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 022207 for MORPHINE SULFATE, sponsored by HIKMA, 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 022207?
NDA 022207 is the application under which FDA issued this approval letter for MORPHINE SULFATE to HIKMA. 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.