FDA.reportPublic FDA data

Application 206787

Type
ANDA
Sponsor
AMNEAL PHARMS CO

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
65162-042Eletriptan HydrobromideEletriptan HydrobromideAmneal Pharmaceuticals LLCANDACurrent
65162-042Eletriptan HydrobromideEletriptan HydrobromideAmneal Pharmaceuticals LLCANDACurrent
65162-042Eletriptan HydrobromideEletriptan HydrobromideAmneal Pharmaceuticals LLCANDACurrent
65162-042Eletriptan HydrobromideEletriptan HydrobromideAmneal Pharmaceuticals LLCANDACurrent
65162-042Eletriptan HydrobromideEletriptan HydrobromideAmneal Pharmaceuticals LLCANDACurrent
65162-043Eletriptan HydrobromideEletriptan HydrobromideAmneal Pharmaceuticals LLCANDACurrent
65162-043Eletriptan HydrobromideEletriptan HydrobromideAmneal Pharmaceuticals LLCANDACurrent
65162-043Eletriptan HydrobromideEletriptan HydrobromideAmneal Pharmaceuticals LLCANDACurrent
65162-043Eletriptan HydrobromideEletriptan HydrobromideAmneal Pharmaceuticals LLCANDACurrent
65162-043Eletriptan HydrobromideEletriptan HydrobromideAmneal Pharmaceuticals LLCANDACurrent