APPLICATION
ANDA075295
TYPE
ANDA
ORIGINAL APPROVAL
1998-10-28
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
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
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 200MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-06-18REMS · Supplement 59AP
2024-10-31REMS · Supplement 57AP
2018-09-18REMS · Supplement 51AP
2017-05-26REMS · Supplement 48AP
2016-09-30REMS · Supplement 47AP
2016-04-20REMS · Supplement 44AP
2015-06-26REMS · Supplement 41AP
2014-08-19REMS · Supplement 38AP
2014-08-11Labeling · Supplement 35 · standardAP
2013-08-28REMS · Supplement 32AP
2012-07-09REMS · Supplement 28AP
2012-07-09Labeling · Supplement 30AP
2010-12-20Labeling · Supplement 26AP
2010-07-02Labeling · Supplement 24AP
2002-11-06Manufacturing (CMC) · Supplement 13AP
2002-11-06Manufacturing (CMC) · Supplement 14AP
2001-11-26Manufacturing (CMC) · Supplement 12AP
2001-08-15Manufacturing (CMC) · Supplement 11AP
2001-01-25Manufacturing (CMC) · Supplement 10AP
2000-09-15Manufacturing (CMC) · Supplement 8AP
2000-09-15Labeling · Supplement 6AP
2000-09-15Labeling · Supplement 9AP
2000-09-15Manufacturing (CMC) · Supplement 7AP
2000-09-15Manufacturing (CMC) · Supplement 5AP
1999-11-03Manufacturing (CMC) · Supplement 4AP
1999-08-12Manufacturing (CMC) · 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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