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FDA ANDA · ANDA200824

MORPHINE SULFATE

Sponsor: RISING

APPLICATION
ANDA200824
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-18
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 100MG · TABLET, EXTENDED RELEASE · ORAL
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 30MG · TABLET, EXTENDED RELEASE · ORAL
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 200MG · TABLET, EXTENDED RELEASE · ORAL
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 60MG · TABLET, EXTENDED RELEASE · ORAL
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 15MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-06-18REMS · Supplement 23AP
2024-10-31REMS · Supplement 21AP
2018-09-18REMS · Supplement 17AP
2017-05-26REMS · Supplement 16AP
2016-09-30REMS · Supplement 14AP
2016-04-20REMS · Supplement 13AP
2015-06-26REMS · Supplement 12AP
2014-08-19REMS · Supplement 8AP
2014-06-25Labeling · Supplement 6 · standardAP
2013-04-15REMS · Supplement 4AP
2012-07-09REMS · Supplement 3AP
2012-07-09Labeling · Supplement 2AP
2011-10-18Not Applicable · Original — Other ↗AP
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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