APPLICATION
ANDA200812
TYPE
ANDA
ORIGINAL APPROVAL
2011-11-10
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
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
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
Approval history
2026-06-18REMS · Supplement 18AP
2025-12-22Labeling · Supplement 17 · standardAP
2024-10-31REMS · Supplement 16AP
2023-12-15Labeling · Supplement 15 · standardAP
2023-12-01Labeling · Supplement 14 · standardAP
2023-12-01Labeling · Supplement 12 · standardAP
2018-09-18REMS · Supplement 13AP
2017-05-26REMS · Supplement 11AP
2016-09-30REMS · Supplement 10AP
2016-04-20REMS · Supplement 8AP
2015-06-26REMS · Supplement 6AP
2015-02-06Labeling · Supplement 3 · standardAP
2014-08-19REMS · Supplement 5AP
2013-04-24Labeling · Supplement 2AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.