Visitor Monitoring Drug History: GRIS-PEG
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: GRIS-PEG
FDA Application No: (NDA) 050475
Active Ingredient(s): GRISEOFULVIN, ULTRAMICROCRYSTALLINE
Company: PEDINOL
 
Label History
 
View the label approved on February 2, 2007 for GRISPEG, (NDA) 050475


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/24/2007 053Labeling Revision Letter
Label 
8/1/2002 051Control Supplement  
6/3/2002 050Control Supplement  
7/2/2001 049Manufacturing Change or Addition  
12/6/2000 048Manufacturing Change or Addition  
4/16/1998 047Control Supplement  
3/26/2003 046Labeling Revision Letter
Label 
4/7/1997 045Control Supplement  
12/21/1982 044Expiration Date Change  
12/21/1982 043Formulation Revision  
6/28/1982 042Labeling Revision  
2/5/1982 041Control Supplement  
7/6/1981 037Expiration Date Change  
3/5/1981 034Expiration Date Change  
3/2/1981 033Package Change  
8/13/1980 032Labeling Revision  
11/21/1980 031Labeling Revision  
1/4/1980 029Control Supplement  
1/4/1980 028Package Change  
1/21/1980 027Expiration Date Change  
4/10/1979 025Formulation Revision  
11/21/1980 024Labeling Revision  
1/17/1978 022Control Supplement  
7/26/1977 021Labeling Revision  
4/20/1977 020Manufacturing Change or Addition  
12/8/1976 019Manufacturing Change or Addition  
11/18/1976 018Labeling Revision  
11/18/1976 017Control Supplement  
10/1/1976 016Package Change  
8/4/1976 015Labeling Revision  
9/16/1976 013Expiration Date Change  
4/1/1976 012Package Change  
1/16/1976 011Control Supplement  
6/20/1975 010Control Supplement  
7/16/1975 009Formulation Revision  
6/20/1988 008Expiration Date Change  
9/16/1986 006Manufacturing Change or Addition  
10/24/1984 004Manufacturing Change or Addition  
4/24/1984 003Manufacturing Change or Addition  
2/17/1983 002Formulation Revision  
1/26/1983 001Manufacturing Change or Addition  
4/16/1975 000Approval  
 
Therapeutic Equivalents
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