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ACTIVE SUBSTANCE / INN

PHENYLEPHRINE HYDROCHLORIDE

Brand name(s): ADVIL MULTI-SYMPTOM COLD & FLU, KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE, PREFRIN-A, VAZCULEP, PHENYLEPHRINE HYDROCHLORIDE, PROMETH VC PLAIN, PHENERGAN VC, MYDCOMBI, ADVIL ALLERGY AND CONGESTION RELIEF, ADVIL CONGESTION RELIEF
FDA LISTED
PRESCRIPTION
OVER-THE-COUNTER
DISCONTINUED
NDA007953
NDA008604
ACTIVE SUBSTANCE
Phenylephrine Hydrochloride
REGULATORS
FDA
SPONSORS / MAH
EXELA PHARMA, EUGIA PHARMA, LUPIN LTD
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
PREFRIN-ANDA007953ALLERGANDiscontinued
VAZCULEPNDA204300EXELA PHARMADiscontinued
PHENYLEPHRINE HYDROCHLORIDEANDA210697EUGIA PHARMAPrescription
MYDCOMBINDA215352EYENOVIADiscontinued
ADVIL CONGESTION RELIEFNDA022565HALEON US HOLDINGSOver-the-counter
PROMETH VC PLAINANDA088761G AND W LABS INCDiscontinued
PHENERGAN VCNDA008604ANI PHARMSDiscontinued
KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDEANDA210183LUPIN LTDPrescription
ADVIL ALLERGY AND CONGESTION RELIEFNDA022113HALEON US HOLDINGSOver-the-counter
ADVIL MULTI-SYMPTOM COLD & FLUNDA022113HALEON US HOLDINGSOver-the-counter

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