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Last Updated: February 19, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209105

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NDA 209105 describes ATOVAQUONE, which is a drug marketed by Abhai Llc, Amneal Pharms, Apotex, Glenmark Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Paddock Llc, Glenmark Generics, and Mylan, and is included in nine NDAs. It is available from eight 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 209105
Applicant:Lupin Ltd
Formulation / Manufacturing:see details
Pharmacology for NDA: 209105
Medical Subject Heading (MeSH) Categories for 209105
Suppliers and Packaging for NDA: 209105
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATOVAQUONE atovaquone SUSPENSION;ORAL 209105 ANDA Lupin Pharmaceuticals, Inc. 68180-282 68180-282-01 1 BOTTLE in 1 CARTON (68180-282-01) > 210 mL in 1 BOTTLE

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson

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