Visitor Monitoring Drug History: BACLOFEN
 
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Label and Approval History

Drug Name: BACLOFEN
FDA Application No: (ANDA) 072825
Active Ingredient(s): BACLOFEN
Company: WATSON LABS
 
Label History
 
Labels are not available on this site for BACLOFEN, (ANDA) 072825
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/2/2003 013Manufacturing Revision  
5/17/2002 012Control Supplement  
4/25/2001 011Control Supplement  
11/30/2000 010Manufacturing Revision  
3/7/2001 009Labeling  
10/23/2000 008Packaging Addition  
8/5/1999 007Chemistry  
8/5/1999 006Chemistry  
12/9/1998 003Chemistry  
8/28/1992 001Chemistry  
9/18/1991 000Approval  
 
Therapeutic Equivalents
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