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Details for New Drug Application (NDA): 077946

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NDA 077946 describes CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Actavis Elizabeth, Apotex Inc, Cipla Ltd, Wockhardt, Bionpharma Inc, Unique Pharm Labs, Sun Pharm Inds Inc, Cadista Pharms, Perrigo R And D, Dr Reddys Labs Ltd, Sandoz, Contract Pharmacal, Aurobindo Pharma Ltd, Orchid Hlthcare, Taro, Ipca Labs Ltd, Mylan, Amneal Pharms Ny, Unichem, Par Pharm Inc, Torrent Pharms Llc, and Sun Pharm Inds Ltd, and is included in twenty-four NDAs. It is available from one hundred and twenty-two suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE ALLERGY profile page.

The generic ingredient in CETIRIZINE HYDROCHLORIDE ALLERGY is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty-two suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

Summary for NDA: 077946

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

Suppliers and Packaging for NDA: 077946

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
TABLET;ORAL 077946 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7522 0615-7522-39 30 TABLET in 1 BLISTER PACK (0615-7522-39)
CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
TABLET;ORAL 077946 ANDA Sandoz Inc 0781-1683 0781-1683-01 100 TABLET in 1 BOTTLE (0781-1683-01)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Dec 27, 2007TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Dec 27, 2007TE:RLD: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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