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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  11/07/2018
 
Trade Name:  Primatene Mist
 
Generic Name or Proper Name (*):  epinephrine
 
Indications Studied:  Temporary relief of mild symptoms of intermittent asthma in adults and children 12 years and older
 
Label Changes Summary:  *Approved for use in adults and pediatric patients 12 years and older. *Not approved in pediatric patients less than 12 years.
 
PREA(P):  P
 
Sponsor:  Armstrong Pharmaceuticals
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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