DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Post-LOEdiphenoxylate hydrochloride and atropine sulfate
ANDAORALTABLET
Approved
Feb 2020
Lifecycle
Post-LOE
Competitive Pressure
30/100
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…