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Last Updated: February 28, 2021

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Details for New Drug Application (NDA): 210510

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NDA 210510 describes ATOVAQUONE, which is a drug marketed by Abhai Llc, Amneal Pharms, Apotex, Glenmark Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Paddock Labs Llc, Glenmark Generics, and Mylan, and is included in nine NDAs. It is available from twelve 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. Ten suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.
Summary for 210510
Applicant:Abhai Llc
Formulation / Manufacturing:see details
Pharmacology for NDA: 210510
Medical Subject Heading (MeSH) Categories for 210510
Suppliers and Packaging for NDA: 210510
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATOVAQUONE atovaquone SUSPENSION;ORAL 210510 ANDA KVK-Tech, Inc. 10702-223 10702-223-21 1 BOTTLE, PLASTIC in 1 CARTON (10702-223-21) > 210 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength750MG/5ML
Approval Date:May 31, 2019TE:ABRLD:No

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