Visitor Monitoring Drug History: LARODOPA
 
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Label and Approval History

Drug Name: LARODOPA
FDA Application No: (NDA) 016912
Active Ingredient(s): LEVODOPA
Company: ROCHE
 
Label History
 
Labels are not available on this site for LARODOPA, (NDA) 016912
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
8/19/1998 048Control Supplement  
5/8/1998 047Control Supplement  
9/5/1997 046Control Supplement  
9/3/1997 045Package Change  
5/30/1997 044Manufacturing Change or Addition  
1/8/1993 043Manufacturing Change or Addition  
1/3/1986 042Labeling Revision  
12/19/1983 041Package Change  
5/17/1983 040Control Supplement  
8/12/1980 037Manufacturing Change or Addition  
6/18/1980 036Formulation Revision  
9/13/1979 035Formulation Revision  
8/5/1977 034Formulation Revision  
8/26/1977 033Formulation Revision  
5/2/1977 032Labeling Revision  
4/29/1977 031Control Supplement  
3/27/1978 030Formulation Revision  
1/14/1977 029Control Supplement  
12/14/1977 028Supplement Pediatric (MarkIV)  
8/22/1975 025Control Supplement  
1/6/1975 023Control Supplement  
11/8/1974 022Distributor  
8/2/1974 020Control Supplement  
8/2/1974 019Control Supplement  
6/4/1970 000Approval  
 
Therapeutic Equivalents
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