APPLICATION
ANDA071051
TYPE
ANDA
ORIGINAL APPROVAL
1986-10-07
LATEST ACTION
2005-10-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ASTRAMORPH PFDiscontinued
MORPHINE SULFATE 0.5MG/ML · INJECTABLE · INJECTION
Approval history
2005-10-21Labeling · Supplement 14AP
2004-09-30Labeling · Supplement 13AP
2002-10-02Labeling · Supplement 12AP
1997-12-22Manufacturing (CMC) · Supplement 10AP
1996-05-31Manufacturing (CMC) · Supplement 9AP
1995-08-25Manufacturing (CMC) · Supplement 8AP
1989-05-03Labeling · Supplement 7AP
1988-04-19Manufacturing (CMC) · Supplement 6AP
1988-04-19Manufacturing (CMC) · Supplement 5AP
1986-10-07OriginalAP
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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