APPLICATION
NDA019436
TYPE
NDA
ORIGINAL APPROVAL
1987-12-31
LATEST ACTION
2007-10-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PRIMACOR · ReferenceDiscontinued
MILRINONE LACTATE EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2002-10-30Manufacturing (CMC) · Supplement 17 · standardAP
2002-09-16Manufacturing (CMC) · Supplement 18 · standardAP
2001-10-18Manufacturing (CMC) · Supplement 15 · standardAP
2001-02-06Manufacturing (CMC) · Supplement 14 · standardAP
2000-11-29Labeling · Supplement 13 · standardAP
1999-07-06Labeling · Supplement 12 · standardAP
1998-03-16Manufacturing (CMC) · Supplement 11 · standardAP
1996-08-15Manufacturing (CMC) · Supplement 9 · standardAP
1995-10-06Labeling · Supplement 7 · standardAP
1995-09-06Manufacturing (CMC) · Supplement 6 · standardAP
1995-06-07Manufacturing (CMC) · Supplement 8 · standardAP
1994-03-01Manufacturing (CMC) · Supplement 5 · standardAP
1992-03-20Labeling · Supplement 3 · standardAP
1991-07-09Manufacturing (CMC) · Supplement 2 · standardAP
1989-07-14Manufacturing (CMC) · Supplement 1 · standardAP
1987-12-31Type 1 - New Molecular Entity · Original · standardAP
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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