← FDA DRUG APPROVALS

FDA NDA · NDA022207

MORPHINE SULFATE

Sponsor: HIKMA

APPLICATION
NDA022207
TYPE
NDA
ORIGINAL APPROVAL
2008-03-17
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MORPHINE SULFATE · ReferencePrescription
MORPHINE SULFATE 15MG · TABLET · ORAL
MORPHINE SULFATE · ReferencePrescription
MORPHINE SULFATE 30MG · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 16 — Letter ↗AP
2025-12-22Labeling · Supplement 14 · standard — Letter ↗AP
2024-10-31REMS · Supplement 13 — Letter ↗AP
2023-12-15Labeling · Supplement 11 · standard — Label ↗AP
2021-06-02Efficacy · Supplement 5 · standard — Label ↗AP
2021-03-04Labeling · Supplement 10 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 9 · standard — Letter ↗AP
2018-09-18Labeling · Supplement 8 · standard — Letter ↗AP
2018-09-18REMS · Supplement 7 — Letter ↗AP
2016-12-16Labeling · Supplement 6 · standard — Letter ↗AP
2012-01-23Labeling · Supplement 4 · unknown — Letter ↗AP
2010-04-15Labeling · Supplement 2 · unknown — Letter ↗AP
2008-03-17Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →