APPLICATION
ANDA078761
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-11
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
MORPHINE SULFATEPrescription
MORPHINE SULFATE 200MG · TABLET, EXTENDED RELEASE · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 60MG · TABLET, EXTENDED RELEASE · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 15MG · TABLET, EXTENDED RELEASE · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 100MG · TABLET, EXTENDED RELEASE · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 30MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-06-18REMS · Supplement 31AP
2024-10-31REMS · Supplement 24AP
2018-09-18REMS · Supplement 13AP
2017-05-26REMS · Supplement 11AP
2016-09-30REMS · Supplement 10AP
2016-04-20REMS · Supplement 8AP
2015-06-26REMS · Supplement 7AP
2014-08-19REMS · Supplement 5AP
2014-06-23Labeling · Supplement 3 · standardAP
2013-04-15Labeling · Supplement 2 · standardAP
2012-09-28Labeling · Supplement 1 · standardAP
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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