APPLICATION
ANDA076720
TYPE
ANDA
ORIGINAL APPROVAL
2004-05-19
LATEST ACTION
2019-12-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 60MG · TABLET, EXTENDED RELEASE · ORAL
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 30MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2019-12-10Labeling · Supplement 25 · standardAP
2019-12-10Labeling · Supplement 24 · standardAP
2019-12-10Labeling · Supplement 22 · standardAP
2018-09-18REMS · Supplement 23AP
2017-05-26REMS · Supplement 21AP
2016-09-30REMS · Supplement 20AP
2016-04-20REMS · Supplement 19AP
2015-06-26REMS · Supplement 17AP
2015-05-08Labeling · Supplement 13AP
2015-04-22Labeling · Supplement 12AP
2008-01-10Labeling · Supplement 7AP
2005-12-23Labeling · Supplement 2AP
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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