Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018831
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRACRIUM ATRACURIUM BESYLATE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
TRACRIUM PRESERVATIVE FREE ATRACURIUM BESYLATE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
11/23/1983 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/26/1999 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2000 SUPPL-22 Labeling

Label is not available on this site.

10/03/2000 SUPPL-21 Labeling

Label is not available on this site.

06/08/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/06/1994 SUPPL-19 Efficacy-New Patient Population

Label is not available on this site.

06/01/1994 SUPPL-18 Labeling

Label is not available on this site.

10/06/1992 SUPPL-17 Labeling

Label is not available on this site.

10/06/1992 SUPPL-16 Labeling

Label is not available on this site.

07/06/1990 SUPPL-15 Labeling

Label is not available on this site.

05/19/1989 SUPPL-14 Labeling

Label is not available on this site.

12/11/1986 SUPPL-13 Labeling

Label is not available on this site.

10/29/1986 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1986 SUPPL-11 Efficacy-New Route Of Administration

Label is not available on this site.

03/13/2009 SUPPL-10 Labeling

Label is not available on this site.

02/14/1986 SUPPL-8 Efficacy-New Patient Population

Label is not available on this site.

10/29/1986 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2009 SUPPL-6 Labeling

Label is not available on this site.

06/24/1985 SUPPL-5 Labeling

Label is not available on this site.

09/11/1985 SUPPL-4 Labeling

Label is not available on this site.

12/17/1984 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1985 SUPPL-2 Labeling

Label is not available on this site.

06/20/1985 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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