"0378-4160-01" National Drug Code (NDC)

Atovaquone And Proguanil Hydrochloride 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4160-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-4160-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4160-01)
Product NDC0378-4160
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAtovaquone And Proguanil Hydrochloride
Non-Proprietary NameAtovaquone And Proguanil Hydrochloride
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20140528
Marketing Category NameANDA
Application NumberANDA202362
ManufacturerMylan Pharmaceuticals Inc.
Substance NameATOVAQUONE; PROGUANIL HYDROCHLORIDE
Strength62.5; 25
Strength Unitmg/1; mg/1
Pharmacy ClassesAntimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]

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