Visitor Monitoring Drug History: DEMULEN 1/35-21
 
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Label and Approval History

Drug Name: DEMULEN 1/35-21
FDA Application No: (NDA) 018168
Active Ingredient(s): ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE
Company: GD SEARLE LLC
 
Label History
 
Labels are not available on this site for DEMULEN 13521, (NDA) 018168
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
9/2/1999 026Labeling Revision  
4/20/1994 025Labeling Revision  
4/28/1993 024Labeling Revision  
12/16/1991 023Control Supplement  
8/7/1991 022Package Change  
10/28/1988 018Control Supplement  
11/14/1991 015Labeling Revision  
10/23/1986 013Labeling Revision  
6/10/1986 012Labeling Revision  
3/13/1986 011Labeling Revision  
6/5/1985 010Labeling Revision  
9/18/1985 009Expiration Date Change  
4/5/1985 008Labeling Revision  
2/12/1985 007Labeling Revision  
9/18/1984 006Labeling Revision  
3/6/1984 004Labeling Revision  
12/30/1981 000Approval  
 
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