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Generated: April 21, 2019

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Details for New Drug Application (NDA): 078780

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NDA 078780 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-eight 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-five suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 078780
Tradename:CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Applicant:Amneal Pharms Ny
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078780
Suppliers and Packaging for NDA: 078780
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078780 ANDA Walgreens 0363-0129 0363-0129-05 1 BLISTER PACK in 1 CARTON (0363-0129-05) > 5 TABLET in 1 BLISTER PACK
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078780 ANDA Walgreens 0363-0129 0363-0129-14 1 BLISTER PACK in 1 CARTON (0363-0129-14) > 14 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Jan 21, 2010TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Jan 21, 2010TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Jan 21, 2010TE:RLD:No

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