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ACTIVE SUBSTANCE / INN

CODEINE PHOSPHATE

Brand name(s): PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE, ACETAMINOPHEN AND CODEINE PHOSPHATE, PHERAZINE W/ CODEINE, ACTIFED W/ CODEINE, BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, TYLENOL W/ CODEINE NO. 3, ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
FDA LISTED
PRESCRIPTION
DISCONTINUED
ANDA081095
NDA012575
ACTIVE SUBSTANCE
Codeine Phosphate
REGULATORS
FDA
SPONSORS / MAH
SANDOZ, HALSEY, HIBROW HLTHCARE
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATEANDA081095MIKARTDiscontinued
ACETAMINOPHEN AND CODEINE PHOSPHATEANDA085291SANDOZDiscontinued
TYLENOL W/ CODEINE NO. 3ANDA087422ORTHO MCNEIL PHARMDiscontinued
BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATEANDA088626WOCKHARDTDiscontinued
PHERAZINE W/ CODEINEANDA088739HALSEYDiscontinued
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEANDA089647PHARM ASSOCDiscontinued
ACETAMINOPHEN AND CODEINE PHOSPHATEANDA211610HIBROW HLTHCAREPrescription
ACTIFED W/ CODEINENDA012575GLAXOSMITHKLINEDiscontinued
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEANDA075231LGM PHARMAPrescription
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEANDA075351NOVITIUM PHARMADiscontinued

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