APPLICATION
ANDA076412
TYPE
ANDA
ORIGINAL APPROVAL
2003-07-31
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
MORPHINE SULFATEPrescription
MORPHINE SULFATE 30MG · TABLET, EXTENDED RELEASE · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 60MG · TABLET, EXTENDED RELEASE · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 15MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-06-18REMS · Supplement 47AP
2024-10-31REMS · Supplement 43AP
2018-09-18REMS · Supplement 28AP
2017-05-26REMS · Supplement 26AP
2016-11-03Labeling · Supplement 24 · standardAP
2016-09-30REMS · Supplement 25AP
2016-04-20REMS · Supplement 22AP
2015-06-26REMS · Supplement 20AP
2015-05-16Labeling · Supplement 19 · standardAP
2014-08-19REMS · Supplement 18AP
2014-08-13Labeling · Supplement 11AP
2014-06-25Labeling · Supplement 15 · standardAP
2013-04-15REMS · Supplement 14AP
2012-07-09Labeling · Supplement 13AP
2012-07-09REMS · Supplement 12AP
2009-07-22Labeling · Supplement 10AP
2004-09-30Labeling · Supplement 5AP
2004-03-19Labeling · Supplement 2AP
2003-11-06Labeling · Supplement 3AP
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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