Visitor Monitoring Drug History: ILOTYCIN
 
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Label and Approval History

Drug Name: ILOTYCIN
FDA Application No: (NDA) 050368
Active Ingredient(s): ERYTHROMYCIN
Company: DISTA
 
Label History
 
Labels are not available on this site for ILOTYCIN, (NDA) 050368
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
7/13/1988 041Manufacturing Change or Addition  
6/28/1982 040Manufacturing Change or Addition  
12/23/1981 039Control Supplement  
2/11/1981 038Control Supplement  
3/24/1981 037Labeling Revision  
1/22/1981 036Labeling Revision  
10/21/1980 035Labeling Revision  
2/6/1980 034Control Supplement  
1/31/1980 033Control Supplement  
2/14/1979 032Control Supplement  
3/6/1978 031Control Supplement  
1/21/1977 030Control Supplement  
3/26/1976 029Labeling Revision  
3/26/1976 028Labeling Revision  
1/29/1976 027Control Supplement  
9/9/1975 026Labeling Revision  
1/28/1975 025Control Supplement  
7/23/1974 024Labeling Revision  
11/12/1973 023Control Supplement  
2/16/1973 022Control Supplement  
11/22/1972 021Control Supplement  
10/31/1972 020Labeling Revision  
11/3/1972 019Labeling Revision  
12/1/1971 018Control Supplement  
12/15/1970 017Control Supplement  
12/15/1969 016Control Supplement  
5/9/1969 015Labeling Revision  
4/28/1969 014Manufacturing Change or Addition  
2/11/1969 013Manufacturing Change or Addition  
1/16/1969 012Control Supplement  
5/17/1967 011Labeling Revision  
7/14/1993 010Labeling Revision  
7/14/1993 009Labeling Revision  
5/22/1987 008Labeling Revision  
5/3/1967 007New Dosage Regimen  
4/15/1986 006Formulation Revision  
3/10/1986 005Labeling Revision  
1/14/1966 004Expiration Date Change  
3/27/1985 003Control Supplement  
3/6/1984 002Package Change  
12/28/1982 001Control Supplement  
6/29/1964 000Approval  
 
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