FDA.reportPublic FDA data

Application 209685

Type
ANDA
Sponsor
GLENMARK PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATOVAQUONEATOVAQUONESUSPENSION;ORAL750MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-900atovaquoneatovaquoneNorthstar Rx LLCANDACurrent
16714-900atovaquoneatovaquoneNorthstar Rx LLCANDACurrent
68462-421atovaquoneatovaquoneGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-421atovaquoneatovaquoneGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-421atovaquoneatovaquoneGlenmark Pharmaceuticals ANDACurrent
68462-421atovaquoneatovaquoneGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-421atovaquoneatovaquoneGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-421atovaquoneatovaquoneGlenmark Pharmaceuticals Inc., USAANDACurrent