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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020343
Company: SANOFI AVENTIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER MILRINONE LACTATE EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER MILRINONE LACTATE EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER 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LACTATE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER 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LACTATE EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/09/1994 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2007 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019436s022, 020343s021ltr.pdf
05/01/2007 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019436s021_020343s020ltr.pdf
04/09/2003 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19436slr019,20343slr014ltr.pdf
09/16/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
10/18/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
11/29/2000 SUPPL-10 Labeling

Label is not available on this site.
05/10/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
07/06/1999 SUPPL-8 Labeling

Label is not available on this site.
10/08/1998 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
02/25/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
08/15/1996 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
06/24/1996 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/13/1996 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.
11/04/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.
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