ACTIVE SUBSTANCE / INN

DEXTROMETHORPHAN HYDROBROMIDE

Brand name(s): DIMETANE-DX, BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE, BROMFED-DM, AUVELITY, GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, PHERAZINE DM
FDA LISTED
PRESCRIPTION
OVER-THE-COUNTER
DISCONTINUED
NDA215430
NDA011265
ACTIVE SUBSTANCE
Dextromethorphan Hydrobromide
REGULATORS
FDA
SPONSORS / MAH
PAR PHARM INC, PERRIGO R AND D, HALSEY
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
BROMFED-DMANDA089681WOCKHARDTDiscontinued
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEANDA202940PHARM ASSOCPrescription
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEANDA202955RHODES PHARMSDiscontinued
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEANDA207602PERRIGO R AND DOver-the-counter
PHERAZINE DMANDA088913HALSEYDiscontinued
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATEANDA202934ACTAVIS ELIZABETHPrescription
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATEANDA202993PAR PHARM INCNone (Tentative Approval)
DIMETANE-DXNDA019279ROBINS AHDiscontinued
AUVELITYNDA215430AXSOMEPrescription
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDENDA011265ANI PHARMSPrescription

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