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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 088009

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NDA 088009 describes LO-TROL, which is a drug marketed by Vangard and is included in one NDA. Additional details are available on the LO-TROL profile page.

The generic ingredient in LO-TROL 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 088009

Tradename:	LO-TROL
Applicant:	Vangard
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:	Mar 25, 1983	TE:		RLD:	No

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