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ACTIVE SUBSTANCE / INN

ACETAMINOPHEN

Brand name(s): INJECTAPAP, ACETAMINOPHEN AND CODEINE PHOSPHATE, OXYCODONE 2.5/APAP 500, TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, HYDROCODONE BITARTRATE AND ACETAMINOPHEN, DARVOCET A500, TYLENOL W/ CODEINE NO. 3, ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, DOLENE AP-65
FDA LISTED
PRESCRIPTION
DISCONTINUED
ANDA085910
ANDA081095
ACTIVE SUBSTANCE
Acetaminophen
REGULATORS
FDA
SPONSORS / MAH
BRISTOL MYERS SQUIBB, GRAVITI PHARMS, SANDOZ
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DARVOCET A500ANDA076429XANODYNE PHARMDiscontinued
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENANDA076914GRAVITI PHARMSDiscontinued
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENANDA077858RISINGPrescription
INJECTAPAPNDA017785ORTHO MCNEIL PHARMDiscontinued
HYDROCODONE BITARTRATE AND ACETAMINOPHENANDA081051MIKARTDiscontinued
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATEANDA081095MIKARTDiscontinued
DOLENE AP-65ANDA085100LEDERLEDiscontinued
ACETAMINOPHEN AND CODEINE PHOSPHATEANDA085291SANDOZDiscontinued
OXYCODONE 2.5/APAP 500ANDA085910BRISTOL MYERS SQUIBBDiscontinued
TYLENOL W/ CODEINE NO. 3ANDA087422ORTHO MCNEIL PHARMDiscontinued

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