Visitor Monitoring Drug History: EPIPEN JR.
 
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Label and Approval History

Drug Name: EPIPEN JR.
FDA Application No: (NDA) 019430
Active Ingredient(s): EPINEPHRINE
Company: MERIDIAN MEDCL TECHN
 
Label History
 
View the label approved on April 15, 2003 for EPIPEN JR., (NDA) 019430


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
12/17/2003 025Labeling Revision Letter 
12/19/2002 018Control Supplement  
8/21/2002 017Control Supplement  
6/28/2002 016Manufacturing Change or Addition  
4/16/2002 015Expiration Date Change  
2/20/2002 014Control Supplement  
8/27/2001 012Labeling Revision Label 
1/11/2001 011Control Supplement  
5/11/2000 010Manufacturing Change or Addition  
11/5/1999 009Manufacturing Change or Addition  
12/15/1999 008Manufacturing Change or Addition  
5/25/1999 007Manufacturing Change or Addition  
1/24/1997 006Manufacturing Change or Addition  
7/25/1996 005Control Supplement  
8/3/1995 004Control Supplement  
3/2/1989 001Labeling Revision  
12/22/1987 000Approval  
 
Therapeutic Equivalents
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