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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 209750

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NDA 209750 describes ATOVAQUONE, which is a drug marketed by Abhai Llc, Amneal Pharms, Apotex, Bionpharma, Chartwell Rx, Glenmark Speclt, Hetero Labs Ltd Iii, Lupin Ltd, Pai Holdings, Glenmark Pharms Ltd, and Mylan, and is included in eleven NDAs. It is available from nineteen suppliers. Additional details are available on the ATOVAQUONE profile page.

The generic ingredient in ATOVAQUONE is atovaquone; proguanil hydrochloride. There are sixteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.

Summary for 209750

Tradename:	ATOVAQUONE
Applicant:	Apotex
Ingredient:	atovaquone
Patents:	0

Medical Subject Heading (MeSH) Categories for 209750

Anti-Infective Agents
Antimalarials
Enzyme Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	750MG/5ML
Approval Date:	Oct 11, 2017	TE:		RLD:	No

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