Visitor Monitoring Drug History: AMBIEN
 
Drugs Directory of False Positives 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: AMBIEN
FDA Application No: (NDA) 019908
Active Ingredient(s): ZOLPIDEM TARTRATE
Company: SANOFI AVENTIS US
 
Label History
 
View the label approved on March 31, 2007 for AMBIEN, (NDA) 019908


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
10/4/2007 025Labeling Revision Letter
Medication Guide 
10/4/2007 024Labeling Revision  
3/28/2007 022Patient Population Altered Letter
Label 
10/4/2007 020Labeling Revision  
9/25/2002 015Manufacturing Change or Addition  
5/21/2002 014Manufacturing Change or Addition  
1/15/2002 013Manufacturing Change or Addition  
11/15/2001 012Manufacturing Change or Addition  
5/4/2001 011Manufacturing Change or Addition  
4/13/2001 010Manufacturing Change or Addition  
12/1/1999 009Labeling Revision  
4/18/1996 005Manufacturing Change or Addition  
10/4/1995 004Control Supplement  
1/9/1995 003Package Change  
7/14/1995 002Labeling Revision Review 
7/14/1995 001Labeling Revision  
12/16/1992 000Approval Review
Other Important Information from FDA 
 
Therapeutic Equivalents
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