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Last Updated: November 21, 2024

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, 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-eight suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 078780
Pharmacology for NDA: 078780
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 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 55910-129 55910-129-45 1 BOTTLE, PLASTIC in 1 BOX (55910-129-45) / 45 TABLET in 1 BOTTLE, PLASTIC
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078780 ANDA P & L Development, LLC 59726-129 59726-129-03 1 BOTTLE, PLASTIC in 1 BOX (59726-129-03) / 300 TABLET in 1 BOTTLE, PLASTIC

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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