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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210789

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NDA 210789 describes DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, which is a drug marketed by Hikma, Able, Ani Pharms, Ascot, Chartwell Rx, Dr Reddys Labs Sa, Fosun Pharma, Heather, Inwood Labs, Kv Pharm, Lannett, Leading, Lederle, Parke Davis, Pharmobedient, Pvt Form, R And S Pharma, Roxane, Specgx Llc, Strides Pharma Intl, Sun Pharm Industries, Unichem, Upsher Smith Labs, Usl Pharma, Valeant Pharm Intl, Watson Labs, and Winder Labs Llc, and is included in twenty-eight NDAs. It is available from eighteen suppliers. Additional details are available on the DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE profile page.

The generic ingredient in DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE is atropine sulfate; diphenoxylate hydrochloride. There are twenty-three drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.

Summary for 210789

Tradename:	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Applicant:	Dr Reddys Labs Sa
Ingredient:	atropine sulfate; diphenoxylate hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.025MG;2.5MG
Approval Date:	Jun 3, 2020	TE:		RLD:	No

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