Drug History: BAYCOL

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

Browse by Letter: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Label and Approval History

Drug Name:	BAYCOL
FDA Application No:	(NDA) 020740
Active Ingredient(s):	CERIVASTATIN SODIUM
Company:	BAYER PHARMS

Label History

View the label approved on April 23, 2002 for BAYCOL, (NDA) 020740

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
5/21/2001	019	Labeling Revision	Label Review Other Important Information from FDA Other
5/10/2001	018	Control Supplement	Label Review
2/27/2001	017	Manufacturing Change or Addition
1/23/2001	016	Expiration Date Change
11/6/2000	014	Labeling Revision	Review
7/21/2000	013	New or Modified Indication	Letter Label Review
7/3/2000	012	Manufacturing Change or Addition	Review
12/22/1999	010	Control Supplement	Review
7/21/2000	008	New Dosage Regimen	Letter Label Review
12/10/1999	007	Control Supplement	Review
3/30/2001	006	Labeling Revision	Letter Label Review
8/23/1999	005	Expiration Date Change
7/13/1999	004	Control Supplement
1/4/1999	003	Labeling Revision	Review
5/24/1999	002	New Dosage Regimen	Letter Review
8/20/1998	001	Control Supplement
6/26/1997	000	Approval

There are no Therapeutic Equivalents