Visitor Monitoring Drug History: EDEX
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
Browse by Letter: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9
Label and Approval History

Drug Name: EDEX
FDA Application No: (NDA) 020649
Active Ingredient(s): ALPROSTADIL
Company: SCHWARZ PHARMA
 
Label History
 
View the label approved on June 12, 2006 for EDEX, (NDA) 020649


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
6/9/2006 015Labeling Revision Letter
Label 
12/14/2001 013Manufacturing Change or Addition  
6/1/2000 012Expiration Date Change  
7/31/2000 011Control Supplement  
3/10/2000 010Control Supplement  
9/6/1999 009Labeling Revision  
10/15/1999 008Manufacturing Change or Addition  
10/20/1999 007Manufacturing Change or Addition  
11/19/1999 006Formulation Revision  
10/20/1999 005Control Supplement  
9/22/1998 004Expiration Date Change  
4/1/1998 003Manufacturing Change or Addition  
7/30/1998 002Control Supplement  
11/5/1997 001Control Supplement  
6/12/1997 000Approval Review 
 
Therapeutic Equivalents
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