Visitor Monitoring Drug History: CORTENEMA
 
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Label and Approval History

Drug Name: CORTENEMA
FDA Application No: (NDA) 016199
Active Ingredient(s): HYDROCORTISONE
Company: ANI PHARMS
 
Label History
 
Labels are not available on this site for CORTENEMA, (NDA) 016199
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
9/25/1996 033Manufacturing Change or Addition  
3/22/1995 032Control Supplement  
11/29/1994 031Package Change  
2/12/1992 030Labeling Revision  
12/28/1993 029Control Supplement  
2/12/1992 028Labeling Revision  
3/24/1992 027Package Change  
6/4/1984 022Manufacturing Change or Addition  
12/19/1979 019Control Supplement  
6/19/1978 018Manufacturing Change or Addition  
12/29/1976 016Expiration Date Change  
1/12/1966 000Approval  
 
Therapeutic Equivalents
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