APPLICATION
ANDA075656
TYPE
ANDA
ORIGINAL APPROVAL
2001-01-30
LATEST ACTION
2015-01-15
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 100MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2015-01-15Labeling · Supplement 7 · standardAP
2003-10-10Labeling · Supplement 4AP
2002-07-15Manufacturing (CMC) · Supplement 3AP
2002-05-08Manufacturing (CMC) · Supplement 2AP
2002-03-27Manufacturing (CMC) · Supplement 1AP
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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