Visitor Monitoring Drug History: LIORESAL
 
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Label and Approval History

Drug Name: LIORESAL
FDA Application No: (NDA) 017851
Active Ingredient(s): BACLOFEN
Company: NOVARTIS
 
Label History
 
Labels are not available on this site for LIORESAL, (NDA) 017851
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
4/11/2000 041Manufacturing Change or Addition  
4/21/1999 040Package Change  
8/18/1995 039Package Change  
8/18/1995 038Control Supplement  
4/5/1990 036Package Change  
11/17/1989 034Labeling Revision  
4/7/1989 031Package Change  
5/14/1985 029Manufacturing Change or Addition  
11/16/1984 028Control Supplement  
2/28/1984 027Manufacturing Change or Addition  
2/15/1984 026Control Supplement  
2/28/1986 025Labeling Revision  
3/21/1984 024Labeling Revision  
3/7/1983 023Control Supplement  
10/18/1982 022Package Change  
3/18/1982 021Package Change  
3/2/1983 019Labeling Revision  
1/24/1985 017Control Supplement  
9/24/1981 016Formulation Revision  
1/20/1982 015Labeling Revision  
5/14/1981 014Formulation Revision  
5/14/1981 013Expiration Date Change  
4/21/1981 012Package Change  
10/6/1980 011Package Change  
5/23/1980 009Manufacturing Change or Addition  
3/19/1980 008Labeling Revision  
2/3/1981 007Package Change  
4/13/1979 006Package Change  
12/31/1979 005Control Supplement  
12/31/1979 004Control Supplement  
3/21/1979 003Package Change  
5/16/1978 002Expiration Date Change  
4/4/1978 001Labeling Revision  
11/22/1977 000Approval  
 
Therapeutic Equivalents
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