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Generated: June 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078862

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NDA 078862 describes CETIRIZINE HYDROCHLORIDE HIVES, which is a drug marketed by Unique Pharm Labs, Jubilant Cadista, Perrigo R And D, Dr Reddys Labs Ltd, Orchid Hlthcare, Ipca Labs Ltd, Mylan, Unichem, Sun Pharm Inds Ltd, Sun Pharm Inds Inc, Bionpharma Inc, Aurobindo Pharma Ltd, Taro, Amneal Pharms Ny, and Torrent Pharms Llc, and is included in sixteen NDAs. It is available from eighty-five suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE HIVES profile page.

The generic ingredient in CETIRIZINE HYDROCHLORIDE HIVES 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: 078862

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078862

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
TABLET;ORAL 078862 ANDA Northstar Rx LLC 16714-271 16714-271-02 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-271-02)
CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
TABLET;ORAL 078862 ANDA Northstar Rx LLC 16714-271 16714-271-03 300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-271-03)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Feb 19, 2009TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Feb 19, 2009TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Feb 19, 2009TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Chubb
Chinese Patent Office
Moodys
Baxter
Federal Trade Commission
Colorcon
Argus Health
Medtronic
Teva

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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