APPLICATION
ANDA202104
TYPE
ANDA
ORIGINAL APPROVAL
2013-06-03
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
MORPHINE SULFATEPrescription
MORPHINE SULFATE 100MG · CAPSULE, EXTENDED RELEASE · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 60MG · CAPSULE, EXTENDED RELEASE · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 10MG · CAPSULE, EXTENDED RELEASE · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 80MG · CAPSULE, EXTENDED RELEASE · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 50MG · CAPSULE, EXTENDED RELEASE · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 20MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2026-06-18REMS · Supplement 29AP
2025-12-22Labeling · Supplement 26 · standardAP
2025-10-09Labeling · Supplement 24 · standardAP
2024-10-31REMS · Supplement 25AP
2023-12-15Labeling · Supplement 23 · standardAP
2021-12-15Labeling · Supplement 13 · standardAP
2021-12-15Labeling · Supplement 18 · standardAP
2021-12-15Labeling · Supplement 14 · standardAP
2018-09-18REMS · Supplement 11AP
2017-05-26REMS · Supplement 9AP
2016-09-30REMS · Supplement 7AP
2016-04-20REMS · Supplement 6AP
2015-06-26REMS · Supplement 5AP
2014-08-19REMS · Supplement 4AP
2014-07-15Labeling · Supplement 2 · 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.
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.