Drug History: ACTONEL

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:	ACTONEL
FDA Application No:	(NDA) 020835
Active Ingredient(s):	RISEDRONATE SODIUM
Company:	PROCTER AND GAMBLE

Label History

View the label approved on July 27, 2007 for ACTONEL, (NDA) 020835

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
7/24/2007	028	Labeling Revision	Letter Label
4/16/2007	025	New Dosage Regimen	Letter Label
8/11/2006	023	Supplement	Letter Label
8/11/2006	022	New or Modified Indication	Letter Label
9/12/2005	020	Labeling Revision	Letter Label
1/24/2006	019	Efficacy Supplement with Clinical Data to Support	Letter Label
5/6/2005	018	Labeling Revision	Letter Label
2/24/2004	014	Labeling Revision	Letter Label Review
12/10/2002	012	Manufacturing Change or Addition	Other
11/5/2002	011	Package Change
9/26/2002	010	Control Supplement
5/17/2002	009	New Dosage Regimen	Letter
5/17/2002	008	New Dosage Regimen	Letter Label
12/21/2001	007	Control Supplement
5/2/2001	005	Control Supplement
4/14/2000	004	New or Modified Indication	Letter Label Review
4/14/2000	003	New or Modified Indication	Letter Label Review
4/14/2000	002	New or Modified Indication	Letter Label Review
4/14/2000	001	New or Modified Indication	Letter Label Review
3/27/1998	000	Approval	Letter Review Consumer Information Sheet

Therapeutic Equivalents