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ACTIVE SUBSTANCE / INN

PROPOXYPHENE HYDROCHLORIDE

Brand name(s): PROPOXYPHENE HYDROCHLORIDE, DOLENE, PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN, PROPOXYPHENE COMPOUND 65, DARVON COMPOUND-65, DARVON W/ ASA, WYGESIC, KESSO-GESIC, DARVON COMPOUND, DOLENE AP-65
FDA LISTED
DISCONTINUED
ANDA083077
ANDA080530
ACTIVE SUBSTANCE
Propoxyphene Hydrochloride
REGULATORS
FDA
SPONSORS / MAH
IVAX SUB TEVA PHARMS, SANDOZ, HERITAGE PHARMS INC
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
PROPOXYPHENE COMPOUND 65ANDA083077IVAX SUB TEVA PHARMSDiscontinued
DOLENE AP-65ANDA085100LEDERLEDiscontinued
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHENANDA089959SANDOZDiscontinued
PROPOXYPHENE HYDROCHLORIDEANDA083125SANDOZDiscontinued
WYGESICANDA084999CARACODiscontinued
DARVON COMPOUND-65NDA010996XANODYNE PHARMDiscontinued
DARVON W/ ASANDA010996XANODYNE PHARMDiscontinued
DARVON COMPOUNDNDA010996XANODYNE PHARMDiscontinued
DOLENEANDA080530HERITAGE PHARMS INCDiscontinued
KESSO-GESICANDA083544MK LABSDiscontinued

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