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Last Updated: October 13, 2024

Details for New Drug Application (NDA): 207833


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NDA 207833 describes ATOVAQUONE, which is a drug marketed by Abhai Llc, Abon Pharms Llc, Amneal Pharms, Apotex, Bionpharma, Chartwell Rx, Glenmark Speclt, Hetero Labs Ltd Iii, Lupin Ltd, Glenmark Pharms Ltd, and Mylan, and is included in eleven NDAs. It is available from eighteen 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 207833
Tradename:ATOVAQUONE
Applicant:Chartwell Rx
Ingredient:atovaquone
Patents:0
Pharmacology for NDA: 207833
Medical Subject Heading (MeSH) Categories for 207833
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:RXDosage:SUSPENSION;ORALStrength750MG/5ML
Approval Date:Apr 28, 2017TE:ABRLD:No

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