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ACTIVE SUBSTANCE / INN

GUAIFENESIN

Brand name(s): XTRELUS, GUAIFENESIN, OBREDON, MUCINEX DM, FLOWTUSS, MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, HYCOFENIX
FDA LISTED
OVER-THE-COUNTER
DISCONTINUED
ANDA091071
NDA217338
ACTIVE SUBSTANCE
Guaifenesin
REGULATORS
FDA
SPONSORS / MAH
SOVEREIGN PHARMS, PERRIGO R AND D, GRANULES
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEANDA207602PERRIGO R AND DOver-the-counter
GUAIFENESINANDA209215GUARDIAN DRUGOver-the-counter
XTRELUSNDA208085ECI PHARMS LLCDiscontinued
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEANDA091071ACTAVIS LABS FLOver-the-counter
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEANDA216082GRANULESDiscontinued
MUCINEX DMNDA021620RB HLTHOver-the-counter
FLOWTUSSNDA022424CHARTWELL RXDiscontinued
HYCOFENIXNDA022279CHARTWELL RXDiscontinued
OBREDONNDA205474SOVEREIGN PHARMSDiscontinued
MUCINEX 12HR COLD & FEVER MULTI-SYMPTOMNDA217338RB HLTHOver-the-counter

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