Visitor Monitoring Drug History: ROBINUL FORTE
 
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Label and Approval History

Drug Name: ROBINUL FORTE
FDA Application No: (NDA) 012827
Active Ingredient(s): GLYCOPYRROLATE
Company: SCIELE PHARMA INC
 
Label History
 
Labels are not available on this site for ROBINUL FORTE, (NDA) 012827
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
7/25/2003 049Package Change Letter 
10/18/2002 048Manufacturing Change or Addition  
6/21/2002 047Manufacturing Change or Addition  
1/15/2002 046Package Change  
1/15/2002 045Manufacturing Change or Addition  
12/7/1999 044Manufacturing Change or Addition  
1/23/1998 043Manufacturing Change or Addition  
2/13/1990 041Manufacturing Change or Addition  
10/27/1988 040Manufacturing Change or Addition  
8/19/1988 038Manufacturing Change or Addition  
3/15/1988 037Control Supplement  
9/16/1986 036Control Supplement  
4/22/1986 035Control Supplement  
7/16/1985 034Labeling Revision  
11/7/1983 033Formulation Revision  
11/7/1983 032Formulation Revision  
1/4/1983 031Manufacturing Change or Addition  
11/3/1982 030Package Change  
2/18/1982 029Package Change  
11/6/1981 028Package Change  
2/5/1981 026Manufacturing Change or Addition  
1/30/1981 025Control Supplement  
1/30/1981 024Package Change  
6/26/1980 023Package Change  
1/7/1980 022Labeling Revision  
1/7/1980 021Control Supplement  
7/24/1979 020Labeling Revision  
4/12/1979 019Labeling Revision  
4/6/1979 018Labeling Revision  
2/22/1979 017Control Supplement  
8/23/1978 016Expiration Date Change  
9/27/1977 015Control Supplement  
7/13/1977 014Control Supplement  
12/29/1976 013Control Supplement  
7/9/1976 012Package Change  
2/18/1976 011Expiration Date Change  
2/18/1976 010Expiration Date Change  
2/18/1976 009Control Supplement  
12/17/1975 008Other Amendment  
8/11/1961 000Approval  
 
Therapeutic Equivalents
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