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Last Updated: February 28, 2021

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Details for New Drug Application (NDA): 202362

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NDA 202362 describes ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, which is a drug marketed by Glenmark Generics and Mylan and is included in two NDAs. It is available from seven suppliers. Additional details are available on the ATOVAQUONE AND PROGUANIL HYDROCHLORIDE profile page.

The generic ingredient in ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 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 202362
Pharmacology for NDA: 202362
Suppliers and Packaging for NDA: 202362
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE atovaquone; proguanil hydrochloride TABLET;ORAL 202362 ANDA Mylan Pharmaceuticals Inc. 0378-4160 0378-4160-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4160-01)
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE atovaquone; proguanil hydrochloride TABLET;ORAL 202362 ANDA Mylan Pharmaceuticals Inc. 0378-4162 0378-4162-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4162-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength62.5MG;25MG
Approval Date:May 27, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG;100MG
Approval Date:May 27, 2014TE:ABRLD:No

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