ACTIVE SUBSTANCE / INN

LOPERAMIDE HYDROCHLORIDE

Brand name(s): IMODIUM, LOPERAMIDE HYDROCHLORIDE, IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, IMODIUM MULTI-SYMPTOM RELIEF
FDA LISTED
PRESCRIPTION
OVER-THE-COUNTER
DISCONTINUED
ANDA073187
NDA017690
ACTIVE SUBSTANCE
Loperamide Hydrochloride
REGULATORS
FDA
SPONSORS / MAH
PERRIGO, BIONPHARMA, ZYDUS LIFESCIENCES
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
LOPERAMIDE HYDROCHLORIDEANDA073187ALPHARMA US PHARMSDiscontinued
LOPERAMIDE HYDROCHLORIDEANDA074091OHM LABSOver-the-counter
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONEANDA213484BIONPHARMAOver-the-counter
LOPERAMIDE HYDROCHLORIDEANDA217471ZYDUS LIFESCIENCESPrescription
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONEANDA076029PERRIGODiscontinued
IMODIUMNDA017690J AND J CONSUMER INCDiscontinued
IMODIUM MULTI-SYMPTOM RELIEFNDA020606J AND J CONSUMER INCDiscontinued
IMODIUM A-DNDA019487KENVUE BRANDSDiscontinued
IMODIUM A-DNDA019487KENVUE BRANDSOver-the-counter
IMODIUM MULTI-SYMPTOM RELIEFNDA021140KENVUE BRANDSOver-the-counter

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