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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 210692


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NDA 210692 describes ATOVAQUONE, which is a drug marketed by Abhai Llc, Abon Pharms Llc, Amneal Pharms, Apotex, Bionpharma, Chartwell Rx, Glenmark Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Glenmark Generics, and Mylan, and is included in eleven NDAs. It is available from fifteen 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. Nine suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.
Summary for 210692
Tradename:ATOVAQUONE
Applicant:Hetero Labs Ltd Iii
Ingredient:atovaquone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210692
Medical Subject Heading (MeSH) Categories for 210692
Suppliers and Packaging for NDA: 210692
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATOVAQUONE atovaquone SUSPENSION;ORAL 210692 ANDA PAI Holdings, LLC 0121-0898 0121-0898-18 3 TRAY in 1 CASE (0121-0898-18) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0898-05)
ATOVAQUONE atovaquone SUSPENSION;ORAL 210692 ANDA PAI Holdings, LLC 0121-0898 0121-0898-42 7 TRAY in 1 CASE (0121-0898-42) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0898-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength750MG/5ML
Approval Date:Oct 11, 2018TE:ABRLD:No

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