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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019436
Company: SANOFI AVENTIS US

Products on NDA 019436

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PRIMACOR	MILRINONE LACTATE	EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019436

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.

Labels for NDA 019436

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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