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FDA NDA · NDA019516

MS CONTIN

morphine sulfate

Sponsor: KNOA PHARMA

APPLICATION
NDA019516
TYPE
NDA
ORIGINAL APPROVAL
1987-05-29
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

MS CONTIN · ReferencePrescription
MORPHINE SULFATE 200MG · TABLET, EXTENDED RELEASE · ORAL
MS CONTIN · ReferencePrescription
MORPHINE SULFATE 15MG · TABLET, EXTENDED RELEASE · ORAL
MS CONTIN · ReferencePrescription
MORPHINE SULFATE 30MG · TABLET, EXTENDED RELEASE · ORAL
MS CONTIN · ReferencePrescription
MORPHINE SULFATE 100MG · TABLET, EXTENDED RELEASE · ORAL
MS CONTIN · ReferencePrescription
MORPHINE SULFATE 60MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-06-18REMS · Supplement 63 — Letter ↗AP
2025-12-22Labeling · Supplement 62 · standard — Letter ↗AP
2024-10-31REMS · Supplement 60 — Letter ↗AP
2023-12-15Labeling · Supplement 58 · standard — Label ↗AP
2021-03-04Labeling · Supplement 57 · standard — Label ↗AP
2019-10-07Labeling · Supplement 55 · standard — Label ↗AP
2018-09-18Labeling · Supplement 54 · standard — Letter ↗AP
2018-09-18REMS · Supplement 53 — Letter ↗AP
2017-05-26REMS · Supplement 52 — Letter ↗AP
2016-12-16Labeling · Supplement 49 · standard — Letter ↗AP
2016-09-30REMS · Supplement 50 — Letter ↗AP
2016-04-20REMS · Supplement 47 — Letter ↗AP
2015-06-26REMS · Supplement 46 — Letter ↗AP
2014-10-22Labeling · Supplement 43 · standard — Letter ↗AP
2014-08-19REMS · Supplement 44 — Letter ↗AP
2014-06-02Manufacturing (CMC) · Supplement 40 · priorityAP
2014-04-16Labeling · Supplement 42 · 901 required — Letter ↗AP
2013-04-15REMS · Supplement 38 — Letter ↗AP
2012-07-09REMS · Supplement 36 — Letter ↗AP
2012-07-09Labeling · Supplement 37 · standard — Letter ↗AP
2010-05-11Labeling · Supplement 34 · unknown — Letter ↗AP
2007-05-11Labeling · Supplement 30 · standard — Letter ↗AP
2003-08-06Labeling · Supplement 21 · standard — Letter ↗AP
2003-02-21Manufacturing (CMC) · Supplement 19 · priority — Letter ↗AP
2001-12-18Labeling · Supplement 16 · standardAP
2001-02-12Labeling · Supplement 15 · standardAP
2000-06-27Manufacturing (CMC) · Supplement 13 · priorityAP
2000-05-12Manufacturing (CMC) · Supplement 8 · priorityAP
2000-05-02Manufacturing (CMC) · Supplement 11 · priorityAP
2000-05-02Manufacturing (CMC) · Supplement 9 · priorityAP
2000-05-02Manufacturing (CMC) · Supplement 14 · priorityAP
2000-05-02Manufacturing (CMC) · Supplement 12 · priorityAP
2000-05-02Manufacturing (CMC) · Supplement 10 · priorityAP
1997-04-29Manufacturing (CMC) · Supplement 7 · priorityAP
1993-11-08Manufacturing (CMC) · Supplement 4 · priorityAP
1990-04-12Manufacturing (CMC) · Supplement 6 · priorityAP
1990-01-16Manufacturing (CMC) · Supplement 3 · priorityAP
1989-09-12Manufacturing (CMC) · Supplement 2 · priorityAP
1988-05-02Manufacturing (CMC) · Supplement 5 · priorityAP
1988-04-08Manufacturing (CMC) · Supplement 1 · priorityAP
VIEW ON DRUGS@FDA ↗

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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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