Application Nr Approved Date Route Status External Links
ANDA091264 None Oral None 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 1-Receptor Antagonist Indicated For: • The Treatment Of The Uncomplicated Skin Manifestations Of Chronic Idiopathic Urticaria ( 1.3 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. 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 (0 Total)

None

Active Ingredients ( 1 Total)

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

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