Visitor Monitoring Drug History: SILVADENE
 
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Label and Approval History

Drug Name: SILVADENE
FDA Application No: (NDA) 017381
Active Ingredient(s): SILVER SULFADIAZINE
Company: KING PHARMS
 
Label History
 
Labels are not available on this site for SILVADENE, (NDA) 017381
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/29/2004 041Labeling Revision Letter 
9/27/2001 040Manufacturing Change or Addition  
11/4/1993 039Manufacturing Change or Addition  
12/7/1992 038Control Supplement  
2/27/1992 037Control Supplement  
5/13/1991 036Control Supplement  
1/29/1991 035Manufacturing Change or Addition  
10/5/1992 034Labeling Revision  
11/14/1988 032Labeling Revision  
10/29/1987 031Control Supplement  
11/28/1986 030Labeling Revision  
11/15/1985 029Formulation Revision  
6/12/1984 028Formulation Revision  
5/31/1984 027Expiration Date Change  
12/6/1982 025Manufacturing Change or Addition  
12/6/1982 024Formulation Revision  
9/10/1982 023Package Change  
4/19/1982 022Package Change  
9/15/1982 021Expiration Date Change  
4/19/1982 020Control Supplement  
3/4/1981 019Control Supplement  
8/28/1981 018Manufacturing Change or Addition  
6/26/1980 017Control Supplement  
11/26/1979 016Control Supplement  
6/14/1979 015Labeling Revision  
7/6/1979 014Manufacturing Change or Addition  
4/17/1979 012Control Supplement  
7/24/1978 011Labeling Revision  
9/28/1978 010Control Supplement  
1/31/1978 009Control Supplement  
4/6/1977 008Control Supplement  
5/2/1977 007Package Change  
5/24/1977 006Manufacturing Change or Addition  
1/24/1977 004Control Supplement  
7/17/1975 002Control Supplement  
11/11/1974 001Labeling Revision  
11/26/1973 000Approval  
 
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