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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203646

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NDA 203646 describes LEVOCETIRIZINE DIHYDROCHLORIDE, which is a drug marketed by Apotex Inc, L Perrigo Co, Lannett Co Inc, Taro Pharm Inds, Allied Pharma Inc, Dr Reddys Labs Ltd, Fosun Pharma, Glenmark Generics, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Micro Labs Ltd India, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Sun Pharma Global, Synthon Pharms, and Teva Pharms, and is included in eighteen NDAs. It is available from thirty-two suppliers. Additional details are available on the LEVOCETIRIZINE DIHYDROCHLORIDE profile page.

The generic ingredient in LEVOCETIRIZINE DIHYDROCHLORIDE is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 203646
Pharmacology for NDA: 203646
Suppliers and Packaging for NDA: 203646
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 203646 ANDA AvKARE, Inc. 42291-386 N 42291-386-90
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 203646 ANDA Vensun Pharmaceuticals, Inc. 42543-712 N 42543-712-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Sep 9, 2014TE:ABRLD:No

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