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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 202915

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NDA 202915 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 202915

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	2.5MG/5ML
Approval Date:	Aug 21, 2014	TE:		RLD:	No

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