FDA.reportPublic FDA data

Application 078537

Type
ANDA
Sponsor
NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOMEPIZOLEFOMEPIZOLEINJECTABLE;INJECTION1.5GM/1.5ML (1GM/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3182fomepizolefomepizoleSandoz Inc.ANDACurrent
68475-510FomepizoleFomepizoleNavinta LLCANDACurrent
68475-510FomepizoleFomepizoleNavinta LLCANDACurrent
68475-510FomepizoleFomepizoleNavinta LLCANDACurrent
68475-510FomepizoleFomepizoleNavinta LLCANDACurrent
68475-510FomepizoleFomepizoleNavinta LLCANDACurrent
70710-1478FomepizoleFomepizoleZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1478FomepizoleFomepizoleZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1478FomepizoleFomepizoleZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1478FomepizoleFomepizoleZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1478FomepizoleFomepizoleZydus Pharmaceuticals USA Inc.ANDACurrent