FDA.reportPublic FDA data

Application 210708

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELETRIPTAN HYDROBROMIDEELETRIPTAN HYDROBROMIDETABLET;ORALEQ 20MG BASENoNo
002ELETRIPTAN HYDROBROMIDEELETRIPTAN HYDROBROMIDETABLET;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59651-104Eletriptan HydrobromideEletriptan HydrobromideAurobindo Pharma LimitedANDACurrent
59651-104Eletriptan HydrobromideEletriptan HydrobromideAurobindo Pharma LimitedANDACurrent
59651-104Eletriptan HydrobromideEletriptan HydrobromideAurobindo Pharma LimitedANDACurrent
59651-104Eletriptan HydrobromideEletriptan HydrobromideAurobindo Pharma LimitedANDACurrent
59651-105Eletriptan HydrobromideEletriptan HydrobromideAurobindo Pharma LimitedANDACurrent
59651-105Eletriptan HydrobromideEletriptan HydrobromideAurobindo Pharma LimitedANDACurrent
59651-105Eletriptan HydrobromideEletriptan HydrobromideAurobindo Pharma LimitedANDACurrent
59651-105Eletriptan HydrobromideEletriptan HydrobromideAurobindo Pharma LimitedANDACurrent
63629-8320Eletriptan HydrobromideEletriptan HydrobromideBryant Ranch PrepackANDACurrent
63629-8320Eletriptan HydrobromideEletriptan HydrobromideBryant Ranch PrepackANDACurrent