Drug History: CLIMARA

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:	CLIMARA
FDA Application No:	(NDA) 020375
Active Ingredient(s):	ESTRADIOL
Company:	BAYER HLTHC

Label History

View the label approved on January 5, 2006 for CLIMARA, (NDA) 020375

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
3/28/2007	024	Control Supplement
12/28/2005	023	Labeling Revision	Letter Label
6/22/2005	022	Labeling Revision	Letter Label
3/18/2005	021	Labeling Revision	Letter
1/22/2004	020	Labeling Revision	Letter Label
12/19/2002	018	Manufacturing Change or Addition
9/13/2002	017	Manufacturing Change or Addition
4/5/2001	016	New or Modified Indication	Letter Label Review
4/4/2001	014	Labeling Revision	Letter Label
5/20/1999	013	Labeling Revision	Review
6/11/1998	012	Expiration Date Change	Review
3/5/1999	011	Labeling Revision	Letter Label Review
6/11/1998	010	Control Supplement	Review
3/23/1998	009	Control Supplement	Letter Label Review
2/27/1998	008	Formulation Revision	Review
9/16/1997	007	Control Supplement	Review
4/11/1997	006	New Route of Administration
5/17/1996	005	Manufacturing Change or Addition	Review
10/10/1995	004	Control Supplement	Review
9/22/1995	003	Manufacturing Change or Addition	Review
2/28/1995	002	Manufacturing Change or Addition	Review
4/25/1995	001	Control Supplement	Review
12/22/1994	000	Approval

Therapeutic Equivalents