APPLICATION
ANDA200411
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-12
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 100MG · CAPSULE, EXTENDED RELEASE · ORAL
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 60MG · CAPSULE, EXTENDED RELEASE · ORAL
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 80MG · CAPSULE, EXTENDED RELEASE · ORAL
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 50MG · CAPSULE, EXTENDED RELEASE · ORAL
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 20MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2026-06-18REMS · Supplement 28AP
2025-12-22Labeling · Supplement 27 · standardAP
2025-10-09Labeling · Supplement 24 · standardAP
2024-10-31REMS · Supplement 25AP
2023-12-15Labeling · Supplement 23 · standardAP
2023-12-15Labeling · Supplement 22 · standardAP
2023-12-06Labeling · Supplement 21 · standardAP
2023-12-06Labeling · Supplement 18 · standardAP
2023-12-06Labeling · Supplement 14 · standardAP
2023-12-06Labeling · Supplement 20 · standardAP
2018-09-18REMS · Supplement 10AP
2018-07-19Labeling · Supplement 5 · standardAP
2017-05-26REMS · Supplement 6AP
2017-05-19Manufacturing (CMC) · Supplement 4AP
2016-09-30REMS · Supplement 3AP
2016-04-20REMS · 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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