Details for New Drug Application (NDA): 213513

NDA 213513 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, Micro Labs Ltd India, Perrigo R And D, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, and Us Antibiotics, and is included in twenty-three NDAs. It is available from forty-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. Fifty suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.

Summary for 213513

Tradename:	LEVOCETIRIZINE DIHYDROCHLORIDE
Applicant:	Hetero Labs Ltd Iii
Ingredient:	levocetirizine dihydrochloride
Patents:	0

Pharmacology for NDA: 213513

Mechanism of Action

Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 213513

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	TABLET;ORAL	213513	ANDA	Allegiant Health	69168-451	69168-451-06	120 TABLET, FILM COATED in 1 BOTTLE (69168-451-06)
LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	TABLET;ORAL	213513	ANDA	Allegiant Health	69168-451	69168-451-60	60 TABLET, FILM COATED in 1 BOTTLE (69168-451-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Apr 29, 2020	TE:		RLD:	No

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