DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Pre-Launch

atropine sulfate; diphenoxylate hydrochloride

ANDAORALTABLET

Lifecycle

Pre-Launch

Mechanism of Action

CLINICAL PHARMACOLOGY Diphenoxylate is rapidly and extensively metabolized in man by ester hydrolysis to diphenoxylic acid (difenoxine), which is biologically active and the major metabolite in the blood. After a 5-mg oral dose of carbon-14 labeled diphenoxylate hydrochloride in ethanolic solution…

Company

Pasithea Therapeutics

FL - Miami Beach

External Resources

DailyMed

Full prescribing information

FDA Drugs@FDA

FDA approval history

RxNorm

Drug nomenclature & identifiers