FDA.reportPublic FDA data

Application 091211

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-909Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
33261-900Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
42254-150Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideRebel Distributors CorpANDACurrent
43063-393Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-393Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-393Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-393Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-393Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1302Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideA-S Medication SolutionsANDACurrent
50090-1302Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideA-S Medication SolutionsANDACurrent
50090-1302Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideA-S Medication SolutionsANDACurrent
50090-1302Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideA-S Medication SolutionsANDACurrent
50090-1302Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideA-S Medication SolutionsANDACurrent
50090-1302Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideA-S Medication SolutionsANDACurrent
60760-498Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-498Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-498Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
63187-879Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideProficient Rx LPANDACurrent
63187-879Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideProficient Rx LPANDACurrent
63187-879Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideProficient Rx LPANDACurrent
63187-879Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideProficient Rx LPANDACurrent
68001-245Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideBluePoint LaboratoriesANDACurrent
68001-245Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideBluePoint LaboratoriesANDACurrent
68001-245Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideBluePoint LaboratoriesANDACurrent
68001-245Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideBluePoint LaboratoriesANDACurrent
68258-1104Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideDispensing Solutions, Inc.ANDACurrent
68462-402Atovaquone and Proguanil Hydrochloride PediatricAtovaquone and Proguanil Hydrochloride PediatricGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-402Atovaquone and Proguanil Hydrochloride PediatricAtovaquone and Proguanil Hydrochloride PediatricGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-402Atovaquone and Proguanil Hydrochloride PediatricAtovaquone and Proguanil Hydrochloride PediatricGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-402Atovaquone and Proguanil Hydrochloride PediatricAtovaquone and Proguanil Hydrochloride PediatricGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-402Atovaquone and Proguanil Hydrochloride PediatricAtovaquone and Proguanil Hydrochloride PediatricGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-404Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-404Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-404Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-404Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-404Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil HydrochlorideGlenmark Pharmaceuticals Inc.,USAANDACurrent