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ACTIVE SUBSTANCE / INN

CETIRIZINE HYDROCHLORIDE

Brand name(s): CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE ALLERGY
FDA LISTED
OVER-THE-COUNTER
DISCONTINUED
ANDA079191
ANDA077170
ACTIVE SUBSTANCE
Cetirizine Hydrochloride
REGULATORS
FDA
SPONSORS / MAH
CHARTWELL MOLECULAR, IVAX SUB TEVA PHARMS, REGCON HOLDINGS
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEANDA077170IVAX SUB TEVA PHARMSOver-the-counter
CETIRIZINE HYDROCHLORIDE ALLERGYANDA078780AMNEAL PHARMS NYOver-the-counter
CETIRIZINE HYDROCHLORIDE HIVES RELIEFANDA078780AMNEAL PHARMS NYOver-the-counter
CETIRIZINE HYDROCHLORIDE HIVES RELIEFANDA079191TORRENT PHARMS LLCDiscontinued
CETIRIZINE HYDROCHLORIDE ALLERGYANDA079191TORRENT PHARMS LLCDiscontinued
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYANDA090378CHARTWELL RXDiscontinued
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFANDA090378CHARTWELL RXDiscontinued
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYANDA091130CHARTWELL MOLECULAROver-the-counter
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFANDA091130CHARTWELL MOLECULAROver-the-counter
CETIRIZINE HYDROCHLORIDEANDA218895REGCON HOLDINGSOver-the-counter

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