Visitor Monitoring Drug History: HYDERGINE
 
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Label and Approval History

Drug Name: HYDERGINE
FDA Application No: (NDA) 017993
Active Ingredient(s): ERGOLOID MESYLATES
Company: NOVARTIS
 
Label History
 
Labels are not available on this site for HYDERGINE, (NDA) 017993
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
4/2/2001 035Manufacturing Change or Addition  
8/1/2000 034Manufacturing Change or Addition  
5/10/2000 033Manufacturing Change or Addition  
3/13/2000 032Manufacturing Change or Addition  
6/18/1996 031Control Supplement  
12/7/1995 029Manufacturing Change or Addition  
10/12/1995 028Control Supplement  
11/12/1998 027Labeling Revision  
9/14/1993 026Package Change  
2/28/1994 023Control Supplement  
2/28/1994 021Control Supplement  
11/7/1989 020Package Change  
5/26/1987 019Control Supplement  
2/7/1985 017Expiration Date Change  
10/26/1983 016Labeling Revision  
2/3/1983 014Labeling Revision  
9/15/1982 012Control Supplement  
1/19/1983 011Manufacturing Change or Addition  
3/25/1982 010Package Change  
8/10/1981 009Manufacturing Change or Addition  
9/2/1981 008Control Supplement  
2/3/1981 007Package Change  
12/11/1979 005Manufacturing Change or Addition  
2/4/1981 004Labeling Revision  
4/5/1979 003Manufacturing Change or Addition  
8/1/1979 002Manufacturing Change or Addition  
6/30/1978 001Package Change  
12/30/1977 000Approval  
 
Therapeutic Equivalents
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