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Active ingredient

Atovaquone

25 finished FDA listings contain Atovaquone as their only active ingredient; 12 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
ATOVAQUONE
Dosage forms
Suspension
Routes
Oral
Manufacturers / labelers
22
Strengths listed
750 mg/5ml
Brand names in FDA listings
Atovaquone, Atovaquone Oral Suspension, Mepron

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 60212

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020500GLAXOSMITHKLINE LLC1995-02-082
ANDA 202960AMNEAL PHARMS2014-03-183
ANDA 207833CHARTWELL RX2017-04-282
ANDA 210692HETERO LABS LTD III2018-10-117
ANDA 209685GLENMARK SPECLT2018-11-211
ANDA 210510ABHAI LLC2019-05-312
ANDA 212918BIONPHARMA2021-03-304
ANDA 214272PAI HOLDINGS2021-10-254

Official labeling on DailyMed

Showing the 12 most recent of 23 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.