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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 209105

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NDA 209105 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 209105

Tradename:	ATOVAQUONE
Applicant:	Lupin Ltd
Ingredient:	atovaquone
Patents:	0

Medical Subject Heading (MeSH) Categories for 209105

Anti-Infective Agents
Antimalarials
Enzyme Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	750MG/5ML
Approval Date:	Sep 11, 2018	TE:	AB	RLD:	No

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