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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:  01/30/2002
Trade Name:  Xopenex Inhalation Solution
Generic Name or Proper Name (*):  levalbuterol
Indications Studied:  Treatment and prevention of bronchspasm
Label Changes Summary:  * Approved down to 6 years of age; recommended dose is 0.31mg TID for patients 6-11 years of age
Product Labeling:  Labeling  Opens a new window
Pediatric Rule (R):  R
Sponsor:  Sepracor
Therapeutic Category:  Antiasthmatic