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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078398

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NDA 078398 describes CETIRIZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Allied Pharma Inc, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Bio Pharm Inc, Breckenridge Pharm, Perrigo R And D, Ranbaxy Labs Ltd, Silarx, Taro, Teva Pharms, Vintage, Wockhardt, Bionpharma Inc, Strides Pharma, Sun Pharm Inds Inc, Actavis Elizabeth, Amneal Pharms Ny, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Ipca Labs Ltd, Jubilant Cadista, Mylan, Orchid Hlthcare, Sandoz, Sun Pharm Inds Ltd, Torrent Pharms Llc, Unichem, Unique Pharm Labs, and Ivax Sub Teva Pharms, and is included in forty-two NDAs. It is available from fifteen suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE profile page.

The generic ingredient in CETIRIZINE HYDROCHLORIDE is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for 078398

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078398

Suppliers and Packaging for NDA: 078398

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride SYRUP;ORAL 078398 ANDA Rebel Distributors Corp 21695-878 21695-878-04 120 mL in 1 BOTTLE (21695-878-04)
CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride SYRUP;ORAL 078398 ANDA Perrigo New York Inc 45802-626 45802-626-26 1 BOTTLE in 1 CARTON (45802-626-26) > 120 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Jun 17, 2008TE:AARLD:No


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