Visitor Monitoring Drug History: URECHOLINE
 
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Label and Approval History

Drug Name: URECHOLINE
FDA Application No: (NDA) 006536
Active Ingredient(s): BETHANECHOL CHLORIDE
Company: ODYSSEY PHARMS
 
Label History
 
Labels are not available on this site for URECHOLINE, (NDA) 006536
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/20/1998 043Control Supplement  
3/31/1998 042Control Supplement  
8/14/1997 041Control Supplement  
9/3/1996 040Manufacturing Change or Addition  
3/11/1996 039Control Supplement  
4/2/1998 038Labeling Revision  
9/11/1995 037Manufacturing Change or Addition  
8/9/1993 036Labeling Revision  
8/28/1992 035Control Supplement  
3/9/1987 034Labeling Revision  
9/12/1985 033Control Supplement  
7/3/1985 032Package Change  
10/11/1984 031Package Change  
10/24/1984 030Control Supplement  
9/16/1983 029Formulation Revision  
1/14/1986 028Practioner Draft Labeling  
7/14/1981 027Package Change  
11/3/1981 026Manufacturing Change or Addition  
6/17/1981 025Package Change  
12/22/1980 024Formulation Revision  
5/1/1980 023Labeling Revision  
5/29/1980 022Control Supplement  
6/24/1980 021Labeling Revision  
8/13/1979 020Labeling Revision  
5/1/1980 018Labeling Revision  
5/1/1980 017Labeling Revision  
10/2/1978 016Labeling Revision  
12/12/1977 015Control Supplement  
9/19/1977 014Labeling Revision  
5/17/1976 013Labeling Revision  
5/17/1976 012Control Supplement  
10/12/1948 000Approval  
 
There are no Therapeutic Equivalents
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