Application 213349

Type
ANDA
Sponsor
AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 2.5MG BASENoNo
002NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 5MG BASENoNo
003NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 10MG BASENoNo
004NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 20MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27241-179NebivololNebivololAjanta Pharma USA Inc.ANDACurrent
27241-180NebivololNebivololAjanta Pharma USA Inc.ANDACurrent
27241-181NebivololNebivololAjanta Pharma USA Inc.ANDACurrent
27241-182NebivololNebivololAjanta Pharma USA Inc.ANDACurrent