Application Nr Approved Date Route Status External Links
ANDA090362 2013-01-31 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Levocetirizine Dihydrochloride Tablet Is A Histamine H1-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. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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