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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 090486

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NDA 090486 describes LEVOCETIRIZINE DIHYDROCHLORIDE, which is a drug marketed by Apotex, Chartwell Molecular, Padagis Us, Taro, Dr Reddys, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules, Hetero Labs Ltd Iii, Ipca Labs Ltd, Macleods Pharms Ltd, Micro Labs Ltd India, Perrigo R And D, Sankalp Lifecare, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Inds Ltd, Synthon Bv, Teva Pharms, and Us Antibiotics, and is included in twenty-three NDAs. It is available from fifty-one 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. Fifty-two suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.

Summary for 090486

Tradename:	LEVOCETIRIZINE DIHYDROCHLORIDE
Applicant:	Granules
Ingredient:	levocetirizine dihydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 26, 2013	TE:		RLD:	No

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