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FDA ANDA · ANDA203602

MORPHINE SULFATE

Sponsor: NOVEL LABS INC

APPLICATION
ANDA203602
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-16
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

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
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 100MG · TABLET, EXTENDED RELEASE · ORAL
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 30MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-06-18REMS · Supplement 12AP
2025-02-03Labeling · Supplement 11 · standardAP
2025-02-03Labeling · Supplement 9 · standardAP
2025-02-03Labeling · Supplement 5 · standardAP
2025-02-03Labeling · Supplement 8 · standardAP
2025-02-03Labeling · Supplement 2 · standardAP
2024-10-31REMS · Supplement 10AP
2018-09-18REMS · Supplement 7AP
2017-05-26REMS · Supplement 6AP
2016-09-30REMS · Supplement 4AP
2016-04-20REMS · Supplement 1AP
2015-12-16UNKNOWN · Original — REMS ↗AP
VIEW ON DRUGS@FDA ↗

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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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