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Details for New Drug Application (NDA): 078870

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NDA 078870 describes CETIRIZINE HYDROCHLORIDE, which is a drug marketed by Taro, Apotex Inc, Actavis Mid Atlantic, Aurobindo Pharma Ltd, Wockhardt, Amneal Pharms, Bio Pharm Inc, Ranbaxy Labs Ltd, Silarx, Teva Pharms, Breckenridge Pharm, Nostrum Labs Inc, Vintage, Perrigo R And D, Actavis Elizabeth, Cipla Ltd, Bionpharma Inc, Unique Pharm Labs, Sun Pharm Inds Inc, Cadista Pharms, Dr Reddys Labs Ltd, Sandoz, Contract Pharmacal, Orchid Hlthcare, Ipca Labs Ltd, Mylan, Amneal Pharms Ny, Unichem, Par Pharm Inc, Torrent Pharms Llc, Sun Pharm Inds Ltd, and Ivax Sub Teva Pharms, and is included in forty-one NDAs. It is available from fourteen 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-four suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for NDA: 078870

Tradename:
CETIRIZINE HYDROCHLORIDE
Applicant:
Bio Pharm Inc
Ingredient:
cetirizine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078870

Suppliers and Packaging for NDA: 078870

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride
SYRUP;ORAL 078870 ANDA Heritage Pharmaceuticals Inc. 23155-292 23155-292-51 120 mL in 1 BOTTLE (23155-292-51)
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride
SYRUP;ORAL 078870 ANDA Heritage Pharmaceuticals Inc. 23155-292 23155-292-52 480 mL in 1 BOTTLE (23155-292-52)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Apr 27, 2009TE:AARLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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