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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
AstraZeneca
Farmers Insurance
Medtronic
Novartis
US Department of Justice
Daiichi Sankyo
Express Scripts
Mallinckrodt
UBS

Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091130

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NDA 091130 describes CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, which is a drug marketed by Cypress Pharm, Jubilant Generics, Allied Pharma Inc, Silarx, Sun Pharma Global, Taro, Aurobindo Pharma, Perrigo R And D, Amneal Pharms, Tris Pharma Inc, Bio Pharm Inc, Actavis Mid Atlantic, Ranbaxy Labs Ltd, and Apotex Inc, and is included in fifteen NDAs. It is available from sixty-one suppliers. Additional details are available on the CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF profile page.

The generic ingredient in CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 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: 091130

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

Suppliers and Packaging for NDA: 091130

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
SYRUP;ORAL 091130 ANDA Silarx Pharmaceuticals, Inc 54838-552 54838-552-40 120 mL in 1 CARTON (54838-552-40)
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
SYRUP;ORAL 091130 ANDA Silarx Pharmaceuticals, Inc 54838-559 54838-559-40 120 mL in 1 CARTON (54838-559-40)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Apr 22, 2011TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Apr 22, 2011TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Daiichi Sankyo
Moodys
US Department of Justice
Farmers Insurance
Colorcon
Teva
Cipla
Julphar
McKesson

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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