FDA.reportPublic FDA data

Application 209105

Type
ANDA
Sponsor
LUPIN LTD

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
0121-0888AtovaquoneAtovaquonePharmaceutical Associates, Inc.ANDACurrent
0121-0888AtovaquoneAtovaquonePharmaceutical Associates, Inc.ANDACurrent
0121-0888AtovaquoneAtovaquonePharmaceutical Associates, Inc.ANDACurrent
0121-0888AtovaquoneAtovaquonePharmaceutical Associates, Inc.ANDACurrent
0121-0888AtovaquoneAtovaquonePharmaceutical Associates, Inc.ANDACurrent
68180-282AtovaquoneAtovaquoneLupin Pharmaceuticals, Inc.ANDACurrent
68180-282AtovaquoneAtovaquoneLupin Pharmaceuticals, Inc.ANDACurrent
68180-282AtovaquoneAtovaquoneLupin Pharmaceuticals, Inc.ANDACurrent