FDA.reportPublic FDA data

Application 201172

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TINIDAZOLETINIDAZOLETABLET;ORAL250MGNoNo
002TINIDAZOLETINIDAZOLETABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0347TinidazoleTinidazoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0347TinidazoleTinidazoleHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0347TinidazoleTinidazoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0347TinidazoleTinidazoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0347TinidazoleTinidazoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0348TinidazoleTinidazoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0348TinidazoleTinidazoleHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0348TinidazoleTinidazoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0348TinidazoleTinidazoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0348TinidazoleTinidazoleWest-Ward Pharmaceuticals Corp.ANDACurrent
67296-1729TinidazoleTinidazoleRedPharm Drug, Inc.ANDACurrent
67296-1729TinidazoleTinidazoleRedPharm Drug, Inc.ANDACurrent