FDA.reportPublic FDA data

Application 208717

Type
ANDA
Sponsor
CADILA PHARMS 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
71209-058NebivololNebivololCadila Pharmaceuticals LimitedANDACurrent
71209-058NebivololNebivololCadila Pharmaceuticals LimitedANDACurrent
71209-059NebivololNebivololCadila Pharmaceuticals LimitedANDACurrent
71209-059NebivololNebivololCadila Pharmaceuticals LimitedANDACurrent
71209-060NebivololNebivololCadila Pharmaceuticals LimitedANDACurrent
71209-060NebivololNebivololCadila Pharmaceuticals LimitedANDACurrent
71209-061NebivololNebivololCadila Pharmaceuticals LimitedANDACurrent
71209-061NebivololNebivololCadila Pharmaceuticals LimitedANDACurrent
72241-032NebivololNebivololModavar Pharmaceuticals LLCANDACurrent
72241-032NebivololNebivololModavar Pharmaceuticals LLCANDACurrent
72241-033NebivololNebivololModavar Pharmaceuticals LLCANDACurrent
72241-033NebivololNebivololModavar Pharmaceuticals LLCANDACurrent
72241-034NebivololNebivololModavar Pharmaceuticals LLCANDACurrent
72241-034NebivololNebivololModavar Pharmaceuticals LLCANDACurrent
72241-035NebivololNebivololModavar Pharmaceuticals LLCANDACurrent
72241-035NebivololNebivololModavar Pharmaceuticals LLCANDACurrent