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Serving 500+ biopharmaceutical companies globally:

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Generated: July 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078336

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NDA 078336 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-four 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 suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

Summary for NDA: 078336

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078336

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
TABLET;ORAL 078336 ANDA L Perrigo Company 0113-9458 0113-9458-04 5 TABLET in 1 VIAL (0113-9458-04)
CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
TABLET;ORAL 078336 ANDA L Perrigo Company 0113-9458 0113-9458-13 5 BLISTER PACK in 1 CARTON (0113-9458-13) > 1 TABLET in 1 BLISTER PACK

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

Summary for product number 003

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


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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
AstraZeneca
Express Scripts
Moodys
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Covington
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Chubb

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