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Last Updated: June 2, 2024

Antidiarrheal Drug Class List

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Drugs in Drug Class: Antidiarrheal

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	207128-001	Oct 21, 2020	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	SOLUTION;ORAL	087708-001	May 3, 1982		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	085762-001	Approved Prior to Jan 1, 1982	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Specgx Llc	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	213335-001	Oct 6, 2020	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lannett	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	085372-001	Approved Prior to Jan 1, 1982	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	210571-001	Aug 31, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Winder Labs Llc	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	211362-001	Jan 27, 2021	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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