Last Updated: May 10, 2026

Details for New Drug Application (NDA): 090362

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NDA 090362 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, 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 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-one suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.

Summary for 090362

Tradename:	LEVOCETIRIZINE DIHYDROCHLORIDE
Applicant:	Sun Pharm
Ingredient:	levocetirizine dihydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jan 31, 2013	TE:	AB	RLD:	No

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