Visitor Monitoring Drug History: PARAFON FORTE DSC
 
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Label and Approval History

Drug Name: PARAFON FORTE DSC
FDA Application No: (NDA) 011529
Active Ingredient(s): CHLORZOXAZONE
Company: ORTHO MCNEIL PHARM
 
Label History
 
Labels are not available on this site for PARAFON FORTE DSC, (NDA) 011529
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
12/1/2000 053Manufacturing Change or Addition  
7/27/2000 052Manufacturing Change or Addition  
6/13/2000 051Manufacturing Change or Addition  
3/4/1996 050Manufacturing Change or Addition  
12/19/1994 049Labeling Revision  
6/28/2002 048Labeling Revision Letter 
1/28/1993 047Control Supplement  
12/16/1991 046Manufacturing Change or Addition  
9/28/1992 045Manufacturing Change or Addition  
12/18/1989 044Manufacturing Change or Addition  
6/10/1992 041Labeling Revision  
6/15/1987 036Formulation Revision  
8/25/1986 032Package Change  
7/15/1985 029Manufacturing Change or Addition  
2/20/1986 028Package Change  
5/29/1984 027Control Supplement  
7/27/1983 026Control Supplement  
6/16/1983 025Manufacturing Change or Addition  
3/29/1983 023Package Change  
3/29/1983 022Package Change  
3/29/1983 021Package Change  
10/27/1981 017Labeling Revision  
4/29/1977 012Formulation Revision  
8/23/1976 011Distributor  
8/15/1958 000Approval  
 
Therapeutic Equivalents
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