Application 210575

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATAZANAVIR SULFATEATAZANAVIR SULFATECAPSULE;ORALEQ 150MG BASENoNo
002ATAZANAVIR SULFATEATAZANAVIR SULFATECAPSULE;ORALEQ 200MG BASENoNo
003ATAZANAVIR SULFATEATAZANAVIR SULFATECAPSULE;ORALEQ 300MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70710-1050ATAZANAVIRATAZANAVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1050ATAZANAVIRATAZANAVIRZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1051ATAZANAVIRATAZANAVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1051ATAZANAVIRATAZANAVIRZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1052ATAZANAVIRATAZANAVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1052ATAZANAVIRATAZANAVIRZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1591ATAZANAVIRATAZANAVIRZydus Lifesciences LimitedANDACurrent
70771-1591ATAZANAVIRATAZANAVIRCadila Healthcare LimitedANDACurrent
70771-1592ATAZANAVIRATAZANAVIRZydus Lifesciences LimitedANDACurrent
70771-1592ATAZANAVIRATAZANAVIRCadila Healthcare LimitedANDACurrent
70771-1593ATAZANAVIRATAZANAVIRZydus Lifesciences LimitedANDACurrent
70771-1593ATAZANAVIRATAZANAVIRCadila Healthcare LimitedANDACurrent