FDA.reportPublic FDA data

Application 202362

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATOVAQUONE AND PROGUANIL HYDROCHLORIDEATOVAQUONE; PROGUANIL HYDROCHLORIDETABLET;ORAL62.5MG;25MGNoNo
002ATOVAQUONE AND PROGUANIL HYDROCHLORIDEATOVAQUONE; PROGUANIL HYDROCHLORIDETABLET;ORAL250MG;100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-4160Atovaquone and Proguanil Hydrochlorideatovaquone and proguanil hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4160Atovaquone and Proguanil Hydrochlorideatovaquone and proguanil hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4160Atovaquone and Proguanil Hydrochlorideatovaquone and proguanil hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4160Atovaquone and Proguanil Hydrochlorideatovaquone and proguanil hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4162Atovaquone and Proguanil Hydrochlorideatovaquone and proguanil hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4162Atovaquone and Proguanil Hydrochlorideatovaquone and proguanil hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4162Atovaquone and Proguanil Hydrochlorideatovaquone and proguanil hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4162Atovaquone and Proguanil Hydrochlorideatovaquone and proguanil hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent