Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018700
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INOCOR INAMRINONE LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Discontinued None No 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
07/31/1984 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
01/28/2000 SUPPL-19 Labeling

Label is not available on this site.

04/19/1995 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-17 Efficacy-New Dosing Regimen

Label is not available on this site.

12/31/1990 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1990 SUPPL-15 Labeling

Label is not available on this site.

12/15/1989 SUPPL-14 Labeling

Label is not available on this site.

08/10/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/03/1988 SUPPL-12 Labeling

Label is not available on this site.

01/07/1988 SUPPL-11 Labeling

Label is not available on this site.

09/24/1987 SUPPL-10 Labeling

Label is not available on this site.

12/15/1989 SUPPL-9 Labeling

Label is not available on this site.

12/07/2007 SUPPL-8 Labeling

Label is not available on this site.

01/15/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/24/1987 SUPPL-6 Labeling

Label is not available on this site.

07/28/1987 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/18/1985 SUPPL-4 Labeling

Label is not available on this site.

05/13/1985 SUPPL-3 Labeling

Label is not available on this site.

12/02/1985 SUPPL-2 Labeling

Label is not available on this site.

09/20/1984 SUPPL-1 Labeling

Label is not available on this site.

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