Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019436
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRIMACOR MILRINONE LACTATE EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
12/31/1987 ORIG-1 Approval Type 1 - New Molecular Entity 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-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019436s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019436s022, 020343s021ltr.pdf
05/01/2007 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019436s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019436s021_020343s020ltr.pdf
04/18/2003 SUPPL-19 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-18 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/2002 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/18/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/06/2001 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/29/2000 SUPPL-13 Labeling

Label is not available on this site.

07/06/1999 SUPPL-12 Labeling

Label is not available on this site.

03/16/1998 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/15/1996 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1995 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1995 SUPPL-7 Labeling

Label is not available on this site.

09/06/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1994 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/20/1992 SUPPL-3 Labeling

Label is not available on this site.

07/09/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/14/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/30/2007 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019436s021s022lbl.pdf
05/01/2007 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019436s021s022lbl.pdf

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