Visitor Monitoring Drug History: HYDERGINE
 
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Label and Approval History

Drug Name: HYDERGINE
FDA Application No: (NDA) 009087
Active Ingredient(s): ERGOLOID MESYLATES
Company: NOVARTIS
 
Label History
 
Labels are not available on this site for HYDERGINE, (NDA) 009087
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
5/10/2000 047Manufacturing Change or Addition  
4/21/1999 046Package Change  
11/12/1998 045Labeling Revision  
9/14/1993 044Package Change  
4/6/1993 041Control Supplement  
11/7/1989 039Package Change  
5/26/1987 038Control Supplement  
10/26/1983 036Labeling Revision  
8/26/1983 035Control Supplement  
2/3/1983 033Labeling Revision  
1/19/1983 031Manufacturing Change or Addition  
8/10/1981 030Manufacturing Change or Addition  
9/2/1981 029Control Supplement  
1/19/1981 028Package Change  
2/24/1981 027Control Supplement  
12/11/1979 026Manufacturing Change or Addition  
6/14/1979 025Package Change  
2/4/1981 024Labeling Revision  
7/13/1978 022Package Change  
10/16/1978 021Manufacturing Change or Addition  
6/27/1978 020Expiration Date Change  
4/14/1978 019Labeling Revision  
3/20/1978 017Package Change  
7/28/1976 013Manufacturing Change or Addition  
6/30/1976 012Package Change  
2/23/1976 011Control Supplement  
11/13/1975 009Control Supplement  
10/6/1975 008Control Supplement  
6/25/1975 007Control Supplement  
6/2/1975 006General Efficacy (MarkIV)  
12/13/1974 005Control Supplement  
4/16/1975 004Other Amendment  
6/25/1974 002Control Supplement  
11/5/1953 000Approval  
 
Therapeutic Equivalents
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