Drug History: OPTIMARK IN PLASTIC CONTAINER

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

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Label and Approval History

Drug Name:	OPTIMARK IN PLASTIC CONTAINER
FDA Application No:	(NDA) 020976
Active Ingredient(s):	GADOVERSETAMIDE
Company:	MALLINCKRODT

Label History

View the label approved on September 6, 2007 for OPTIMARK IN PLASTIC CONTAINER, (NDA) 020976

To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.

Approval History

Action Date	Supplement Number	Approval Type	Letters, Reviews, Labels, Patient Package Insert
9/4/2007	011	Labeling Revision	Letter Label
8/4/2006	009	Efficacy Supplement with Clinical Data to Support	Letter Label
11/23/2005	007	Control Supplement	Letter
11/14/2002	004	Control Supplement
1/31/2003	003	Supplement	Letter Label Review
1/29/2001	002	Control Supplement
12/8/1999	000	Approval	Letter Label Review Other Important Information from FDA

Therapeutic Equivalents