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Last Updated: November 2, 2024

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, Sun Pharm Inds Inc, Amneal Pharms Ny, Taro, and Torrent Pharms Llc, and is included in seven NDAs. It is available from twenty-seven 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 fifty-seven suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 209107
Pharmacology for NDA: 209107
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 WALGREEN CO. 0363-0068 0363-0068-12 1 BOTTLE in 1 CARTON (0363-0068-12) / 40 CAPSULE in 1 BOTTLE
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride CAPSULE;ORAL 209107 ANDA WALGREEN CO. 0363-0068 0363-0068-53 1 BOTTLE in 1 CARTON (0363-0068-53) / 25 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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