APPLICATION
ANDA091357
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-23
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 7AP
2024-10-31REMS · Supplement 6AP
2018-09-18REMS · Supplement 4AP
2017-05-26REMS · Supplement 3AP
2016-09-30REMS · Supplement 1AP
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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