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FDA ANDA · ANDA074769

MORPHINE SULFATE EXTENDED RELEASE

morphine sulfate

Sponsor: RHODES PHARMS

APPLICATION
ANDA074769
TYPE
ANDA
ORIGINAL APPROVAL
1998-07-02
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

MORPHINE SULFATEPrescription
MORPHINE SULFATE 100MG · TABLET, EXTENDED RELEASE · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 200MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-06-18REMS · Supplement 35AP
2018-09-18REMS · Supplement 29AP
2017-05-26REMS · Supplement 28AP
2016-09-30REMS · Supplement 27AP
2016-04-20REMS · Supplement 24AP
2015-06-26REMS · Supplement 22AP
2014-08-19REMS · Supplement 20AP
2014-07-21Labeling · Supplement 19 · standardAP
2013-04-15REMS · Supplement 13AP
2012-09-28Labeling · Supplement 12AP
2012-07-09REMS · Supplement 10AP
2000-07-11Manufacturing (CMC) · Supplement 6AP
2000-07-11Manufacturing (CMC) · Supplement 4AP
2000-07-11Manufacturing (CMC) · Supplement 2AP
2000-07-11Manufacturing (CMC) · Supplement 7AP
2000-07-11Manufacturing (CMC) · Supplement 5AP
2000-07-11Manufacturing (CMC) · Supplement 3AP
1998-07-02Original — Label ↗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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