Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018831
Company: HOSPIRA

Products on NDA 018831

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TRACRIUM	ATRACURIUM BESYLATE	10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No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PRESERVATIVE FREE	ATRACURIUM BESYLATE	10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018831

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.