APPLICATION
ANDA079040
TYPE
ANDA
ORIGINAL APPROVAL
2013-01-16
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
MORPHINE SULFATEPrescription
MORPHINE SULFATE 90MG · 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 120MG · CAPSULE, EXTENDED RELEASE · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 75MG · CAPSULE, EXTENDED RELEASE · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 45MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2026-06-18REMS · Supplement 39AP
2025-12-22Labeling · Supplement 37 · standardAP
2025-10-01Labeling · Supplement 29 · standardAP
2025-04-11Manufacturing (CMC) · Supplement 32 · unknownAP
2024-10-31REMS · Supplement 30AP
2023-12-15Labeling · Supplement 26 · standardAP
2023-12-15Labeling · Supplement 27 · standardAP
2023-12-04Labeling · Supplement 24 · standardAP
2021-03-11Labeling · Supplement 15 · standardAP
2021-03-11Labeling · Supplement 13 · standardAP
2021-03-04Labeling · Supplement 23 · standardAP
2021-02-02Labeling · Supplement 20 · standardAP
2019-10-11Labeling · Supplement 21 · standardAP
2018-09-18REMS · Supplement 18AP
2017-05-26REMS · Supplement 17AP
2016-09-30REMS · Supplement 14AP
2016-04-20REMS · Supplement 11AP
2015-06-26REMS · Supplement 10AP
2014-08-19REMS · Supplement 7AP
2014-07-03Labeling · Supplement 5 · standardAP
2014-07-02Manufacturing (CMC) · Supplement 4 · unknownAP
2013-04-15REMS · Supplement 3AP
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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