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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:  04/11/2013
 
Trade Name:  Doryx
 
Generic Name or Proper Name (*):  doxycycline hyclate
 
Indications Studied:  Uncomplicated urogenital Chlamydia trachomatis infection
 
Label Changes Summary:  * New 200-mg strength tablet * New alternative dosage regimen for adults and children at least 8 years and weighing 45 kg based on studies in adults * New dosage form, new dosage regimen
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Mayne Pharma International
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic
 
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