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FDA NDA · NDA020343
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: SANOFI AVENTIS US
APPLICATION
NDA020343
TYPE
NDA
ORIGINAL APPROVAL
1994-08-09
LATEST ACTION
2007-10-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
MILRINONE LACTATE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
MILRINONE LACTATE EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
MILRINONE LACTATE EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
MILRINONE LACTATE EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2002-09-16Manufacturing (CMC) · Supplement 13 · standardAP
2001-10-18Manufacturing (CMC) · Supplement 11 · standardAP
2000-11-29Labeling · Supplement 10 · standardAP
2000-05-10Manufacturing (CMC) · Supplement 9 · standardAP
1999-07-06Labeling · Supplement 8 · standardAP
1998-10-08Manufacturing (CMC) · Supplement 7 · standardAP
1998-02-25Manufacturing (CMC) · Supplement 6 · standardAP
1996-08-15Manufacturing (CMC) · Supplement 4 · standardAP
1996-08-13Manufacturing (CMC) · Supplement 2 · standardAP
1996-06-24Manufacturing (CMC) · Supplement 3 · standardAP
1994-11-04Manufacturing (CMC) · Supplement 1 · standardAP
1994-08-09Type 3 - New Dosage Form · 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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