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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201653

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NDA 201653 describes LEVOCETIRIZINE DIHYDROCHLORIDE, which is a drug marketed by Apotex Inc, L Perrigo Co, Silarx Pharms 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 twenty-nine 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-two suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 201653
Pharmacology for NDA: 201653
Suppliers and Packaging for NDA: 201653
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 201653 ANDA Ranbaxy Pharmaceuticals Inc. 63304-433 N 63304-433-69
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 201653 ANDA Ranbaxy Pharmaceuticals Inc. 63304-433 N 63304-433-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 26, 2015TE:ABRLD:No

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