Details for New Drug Application (NDA): 091264

NDA 091264 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 091264

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

Pharmacology for NDA: 091264

Mechanism of Action

Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 091264

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	TABLET;ORAL	091264	ANDA	Camber Pharmaceuticals, Inc.	31722-551	31722-551-05	500 TABLET in 1 BOTTLE (31722-551-05)
LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	TABLET;ORAL	091264	ANDA	Camber Pharmaceuticals, Inc.	31722-551	31722-551-10	1000 TABLET in 1 BOTTLE (31722-551-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jun 29, 2012	TE:	AB	RLD:	No

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