Visitor Monitoring Drug History: PROVERA
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: PROVERA
FDA Application No: (NDA) 011839
Active Ingredient(s): MEDROXYPROGESTERONE ACETATE
Company: PHARMACIA AND UPJOHN
 
Label History
 
View the label approved on October 4, 2007 for PROVERA, (NDA) 011839


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 DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
9/28/2007 071Labeling Revision Letter
Label 
8/4/1998 068New or Modified Indication Letter
Review 
3/31/1998 067Labeling Revision  
11/28/1995 066Control Supplement  
6/23/1993 063Package Change  
4/30/1993 062Labeling Revision  
6/23/1993 061Control Supplement  
11/19/1991 060Labeling Revision  
6/19/1992 059Control Supplement  
12/18/1991 058Labeling Revision  
10/6/1989 053Manufacturing Change or Addition  
6/3/1988 052Manufacturing Change or Addition  
10/26/1987 050Labeling Revision  
11/1/1985 046Formulation Revision  
7/23/1979 039General Efficacy (MarkIV)  
6/6/1979 035General Efficacy (MarkIV)  
10/21/1975 029Other Amendment  
10/4/1973 025Control Supplement  
6/18/1959 000Approval  
 
Therapeutic Equivalents
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