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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 214272

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NDA 214272 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 214272

Tradename:	ATOVAQUONE
Applicant:	Pai Holdings
Ingredient:	atovaquone
Patents:	0

Pharmacology for NDA: 214272

Medical Subject Heading (MeSH) Categories for 214272

Anti-Infective Agents
Antimalarials
Enzyme Inhibitors

Suppliers and Packaging for NDA: 214272

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATOVAQUONE	atovaquone	SUSPENSION;ORAL	214272	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0956	0121-0956-08	1 BOTTLE in 1 CARTON (0121-0956-08) / 210 mL in 1 BOTTLE
ATOVAQUONE	atovaquone	SUSPENSION;ORAL	214272	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1016	0121-1016-18	3 TRAY in 1 CASE (0121-1016-18) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1016-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	750MG/5ML
Approval Date:	Oct 25, 2021	TE:	AB	RLD:	No

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