Visitor Monitoring Drug History: PRIMATENE MIST
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: PRIMATENE MIST
FDA Application No: (NDA) 016126
Active Ingredient(s): EPINEPHRINE
Company: WYETH CONS
 
Label History
 
View the label approved on June 10, 2003 for PRIMATENE MIST, (NDA) 016126


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
1/15/2004 029Supplement Review 
1/13/2004 028Supplement Review 
1/25/2002 027Control Supplement Review 
8/30/2001 025Labeling Revision Letter
Label
Review 
11/24/1999 024Manufacturing Change or Addition Review 
11/24/1999 023Control Supplement Review 
5/1/1998 021Manufacturing Change or Addition  
11/24/1999 020Manufacturing Change or Addition Review 
11/17/1995 018Manufacturing Change or Addition  
12/1/1999 017Control Supplement Review 
1/19/1996 016Control Supplement  
10/22/1993 013Manufacturing Change or Addition  
8/9/1991 012Manufacturing Change or Addition  
3/24/1994 011Labeling Revision  
3/24/1994 010Labeling Revision  
3/24/1994 009Labeling Revision  
4/22/1988 008Labeling Revision  
5/19/1988 007Labeling Revision  
10/3/1980 005Labeling Revision  
5/25/1977 004Manufacturing Change or Addition  
10/3/1980 003Labeling Revision  
11/8/1967 000Approval  
 
Therapeutic Equivalents
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