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Generated: January 20, 2019

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Details for New Drug Application (NDA): 209107

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NDA 209107 describes CETIRIZINE HYDROCHLORIDE HIVES RELIEF, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma Inc, Sun Pharm Inds Inc, Amneal Pharms Ny, Taro, and Torrent Pharms Llc, and is included in seven NDAs. It is available from thirty-six suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE HIVES RELIEF profile page.

The generic ingredient in CETIRIZINE HYDROCHLORIDE HIVES RELIEF is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty-one suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 209107
Tradename:CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Applicant:Aurobindo Pharma Ltd
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 209107
Suppliers and Packaging for NDA: 209107
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride CAPSULE;ORAL 209107 ANDA Aurohealth LLC 58602-806 58602-806-04 1 BOTTLE in 1 CARTON (58602-806-04) > 12 CAPSULE in 1 BOTTLE
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride CAPSULE;ORAL 209107 ANDA Aurohealth LLC 58602-806 58602-806-12 1 BOTTLE in 1 CARTON (58602-806-12) > 40 CAPSULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrength10MG
Approval Date:Jul 20, 2018TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrength10MG
Approval Date:Jul 20, 2018TE:RLD:No

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