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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 202960

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NDA 202960 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 202960

Tradename:	ATOVAQUONE
Applicant:	Amneal Pharms
Ingredient:	atovaquone
Patents:	0

Pharmacology for NDA: 202960

Medical Subject Heading (MeSH) Categories for 202960

Anti-Infective Agents
Antimalarials
Enzyme Inhibitors

Suppliers and Packaging for NDA: 202960

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATOVAQUONE	atovaquone	SUSPENSION;ORAL	202960	ANDA	AvPAK	50268-119	50268-119-12	20 CUP in 1 BOX (50268-119-12) / 5 mL in 1 CUP (50268-119-11)
ATOVAQUONE	atovaquone	SUSPENSION;ORAL	202960	ANDA	Amneal Pharmaceuticals LLC	65162-693	65162-693-88	1 BOTTLE in 1 CARTON (65162-693-88) / 210 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	750MG/5ML
Approval Date:	Mar 18, 2014	TE:	AB	RLD:	No

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