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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 209685

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NDA 209685 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 209685

Tradename:	ATOVAQUONE
Applicant:	Glenmark Speclt
Ingredient:	atovaquone
Patents:	0

Pharmacology for NDA: 209685

Medical Subject Heading (MeSH) Categories for 209685

Anti-Infective Agents
Antimalarials
Enzyme Inhibitors

Suppliers and Packaging for NDA: 209685

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATOVAQUONE	atovaquone	SUSPENSION;ORAL	209685	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-421	68462-421-21	210 mL in 1 BOTTLE (68462-421-21)
ATOVAQUONE	atovaquone	SUSPENSION;ORAL	209685	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-421	68462-421-69	42 POUCH in 1 CARTON (68462-421-69) / 5 mL in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	750MG/5ML
Approval Date:	Nov 21, 2018	TE:	AB	RLD:	No

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