Application Nr Approved Date Route Status External Links
ANDA091264 2012-06-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & Usage Levocetirizine Dihydrochloride Is A Histamine H 1-Receptor Antagonist Indicated For: The Treatment Of The Uncomplicated Skin Manifestations Of Chronic Idiopathic Urticaria ( 1.3) 1.3 Chronic Idiopathic Urticaria Levocetirizine Dihydrochloride Tablets Are Indicated For The Treatment Of The Uncomplicated Skin Manifestations Of Chronic Idiopathic Urticaria In Adults And Children 6 Years Of Age And Older. Pediatric Use Information In Pediatric Patients (age 6 Months To 5 Years) Is Approved For Ucb Inc.’s Levocetirizine Dihydrochloride Drug Product Labeling. However, Due To Ucb Inc.‘s Marketing Exclusivity Rights; This Drug Product Is Not Labeled For Such Use In Those Pediatric Patients.

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Levocetirizine Dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE ZINC19364230

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