Details for New Drug Application (NDA): 091263

NDA 091263 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 091263

Tradename:	LEVOCETIRIZINE DIHYDROCHLORIDE
Applicant:	Padagis Us
Ingredient:	levocetirizine dihydrochloride
Patents:	0

Pharmacology for NDA: 091263

Mechanism of Action

Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 091263

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	SOLUTION;ORAL	091263	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-680	45802-680-28	148 mL in 1 BOTTLE (45802-680-28)
LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	SOLUTION;ORAL	091263	ANDA	Bryant Ranch Prepack	63629-2533	63629-2533-1	1 BOTTLE in 1 CARTON (63629-2533-1) / 148 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	2.5MG/5ML
Approval Date:	Nov 7, 2011	TE:	AA	RLD:	No

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