FDA.reportPublic FDA data

Application 203808

Type
ANDA
Sponsor
EDENBRIDGE PHARMS

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
42799-207TinidazoleTinidazoleEdenbridge Pharmaceuticals, LLCANDACurrent
42799-207TinidazoleTinidazoleEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-207TinidazoleTinidazoleEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-207TinidazoleTinidazoleEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-208TinidazoleTinidazoleEdenbridge Pharmaceuticals, LLCANDACurrent
42799-208TinidazoleTinidazoleEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-208TinidazoleTinidazoleEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-208TinidazoleTinidazoleEdenbridge Pharmaceuticals LLC.ANDACurrent
53002-1611TinidazoleTinidazoleRPK Pharmaceuticals, Inc.ANDACurrent
53002-1611TinidazoleTinidazoleRPK Pharmaceuticals, Inc.ANDACurrent