Drug History: PRANDIN

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:	PRANDIN
FDA Application No:	(NDA) 020741
Active Ingredient(s):	REPAGLINIDE
Company:	NOVO NORDISK INC

Label History

View the label approved on February 11, 2005 for PRANDIN, (NDA) 020741

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
6/19/2006	030	Labeling Revision	Letter Review
2/10/2005	022	Labeling Revision	Letter Label
10/15/2003	019	Package Change	Letter Review
8/27/2003	018	Labeling Revision	Letter Label
11/25/2002	016	Expiration Date Change	Review
10/1/2002	015	Control Supplement	Review
8/5/2002	014	Expiration Date Change
10/21/2002	013	New or Modified Indication	Letter Label
1/18/2002	012	Efficacy Supplement with Clinical Data to Support	Letter Label
10/27/2000	010	Control Supplement
8/15/2000	009	Manufacturing Change or Addition	Review
2/25/2000	008	Manufacturing Change or Addition
11/26/1999	007	Control Supplement
12/8/1999	006	Manufacturing Change or Addition
8/30/1999	005	Manufacturing Change or Addition
5/18/1999	004	Control Supplement
5/18/1999	003	Control Supplement
3/1/1999	002	Expiration Date Change
8/10/1999	001	Labeling Revision
12/22/1997	000	Approval

Therapeutic Equivalents