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FDA NDA · NDA022195

MORPHINE SULFATE

Sponsor: HIKMA

APPLICATION
NDA022195
TYPE
NDA
ORIGINAL APPROVAL
2008-03-17
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

MORPHINE SULFATE · ReferencePrescription
MORPHINE SULFATE 100MG/5ML · SOLUTION · ORAL
MORPHINE SULFATE · ReferencePrescription
MORPHINE SULFATE 10MG/5ML · SOLUTION · ORAL
MORPHINE SULFATE · ReferencePrescription
MORPHINE SULFATE 20MG/5ML · SOLUTION · ORAL

Approval history

2026-06-18REMS · Supplement 25 — Letter ↗AP
2025-12-22Labeling · Supplement 24 · standard — Letter ↗AP
2024-10-31REMS · Supplement 23 — Letter ↗AP
2023-12-15Labeling · Supplement 21 · standard — Label ↗AP
2021-07-22Labeling · Supplement 20 · standard — Label ↗AP
2021-06-02Efficacy · Supplement 10 · standard — Letter ↗AP
2021-03-04Labeling · Supplement 19 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 18 · standard — Letter ↗AP
2018-09-18Labeling · Supplement 16 · standard — Letter ↗AP
2018-09-18REMS · Supplement 14 — Letter ↗AP
2016-12-16Labeling · Supplement 11 · standard — Letter ↗AP
2015-04-21Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP
2014-04-18Manufacturing (CMC) · Supplement 8 · standardAP
2014-01-09Labeling · Supplement 9 · standard — Letter ↗AP
2012-01-23Labeling · Supplement 6 · standard — Letter ↗AP
2011-10-18Labeling · Supplement 5 · standard — Letter ↗AP
2011-06-10Labeling · Supplement 4 · unknownAP
2010-01-25Efficacy · Supplement 2 · priority — Label ↗AP
2008-03-17Type 7 - Drug Already Marketed without Approved NDA · Original · standard — REMS ↗AP
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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.

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