Visitor Monitoring Drug History: OPHTHOCORT
 
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Label and Approval History

Drug Name: OPHTHOCORT
FDA Application No: (NDA) 050201
Active Ingredient(s): CHLORAMPHENICOL; HYDROCORTISONE ACETATE; POLYMYXIN B SULFATE
Company: PARKEDALE
 
Label History
 
Labels are not available on this site for OPHTHOCORT, (NDA) 050201
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
8/27/1996 026Labeling Revision  
3/25/1988 025Labeling Revision  
4/19/1983 024Manufacturing Change or Addition  
7/7/1982 023Practioner Draft Labeling  
12/12/1980 022Practioner Draft Labeling  
12/8/1980 021Labeling Revision  
1/22/1980 019Labeling Revision  
12/20/1979 018Manufacturing Change or Addition  
8/29/1978 017Labeling Revision  
6/5/1978 016Manufacturing Change or Addition  
7/18/1973 015Labeling Revision  
8/30/1972 014Labeling Revision  
8/30/1972 013Labeling Revision  
11/9/1970 012Labeling Revision  
12/10/1963 011Labeling Revision  
5/19/1961 008Package Change  
5/19/1961 007Package Change  
6/17/1992 006Manufacturing Change or Addition  
9/29/1986 005Control Supplement  
11/8/1988 004Labeling Revision  
8/15/1983 003Labeling Revision  
7/22/1983 002Manufacturing Change or Addition  
4/19/1983 001Manufacturing Change or Addition  
6/25/1958 000Approval  
 
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