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Last Updated: April 3, 2026

Details for New Drug Application (NDA): 207833

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NDA 207833 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 207833

Tradename:	ATOVAQUONE
Applicant:	Chartwell Rx
Ingredient:	atovaquone
Patents:	0

Pharmacology for NDA: 207833

Medical Subject Heading (MeSH) Categories for 207833

Anti-Infective Agents
Antimalarials
Enzyme Inhibitors

Suppliers and Packaging for NDA: 207833

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATOVAQUONE	atovaquone	SUSPENSION;ORAL	207833	ANDA	Chartwell RX, LLC	62135-528	62135-528-09	210 mL in 1 BOTTLE (62135-528-09)
ATOVAQUONE	atovaquone	SUSPENSION;ORAL	207833	ANDA	Chartwell RX, LLC	62135-528	62135-528-24	2 TRAY in 1 BOX (62135-528-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-528-45)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	750MG/5ML
Approval Date:	Apr 28, 2017	TE:	AB	RLD:	No

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