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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 210692

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NDA 210692 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 210692

Tradename:	ATOVAQUONE
Applicant:	Hetero Labs Ltd Iii
Ingredient:	atovaquone
Patents:	0

Pharmacology for NDA: 210692

Medical Subject Heading (MeSH) Categories for 210692

Anti-Infective Agents
Antimalarials
Enzyme Inhibitors

Suppliers and Packaging for NDA: 210692

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATOVAQUONE	atovaquone	SUSPENSION;ORAL	210692	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-0631	17856-0631-1	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0631-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0631-2)
ATOVAQUONE	atovaquone	SUSPENSION;ORAL	210692	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-8631	17856-8631-1	50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-8631-1) / 5 mL in 1 CUP, UNIT-DOSE

Profile for product number 001

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

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