FDA.reportPublic FDA data

Application 205619

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET;ORALEQ 5MG BASENoNo
002ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET;ORALEQ 10MG BASENoNo
003ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET;ORALEQ 20MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-019Escitalopram OxalateEscitalopram OxalateAmneal Pharmaceuticals LLCANDACurrent
65162-019Escitalopram OxalateEscitalopram OxalateAmneal Pharmaceuticals LLCANDACurrent
65162-019Escitalopram OxalateEscitalopram OxalateAmneal Pharmaceuticals LLCANDACurrent
65162-020Escitalopram OxalateEscitalopram OxalateAmneal Pharmaceuticals LLCANDACurrent
65162-020Escitalopram OxalateEscitalopram OxalateAmneal Pharmaceuticals LLCANDACurrent
65162-020Escitalopram OxalateEscitalopram OxalateAmneal Pharmaceuticals LLCANDACurrent
65162-021Escitalopram OxalateEscitalopram OxalateAmneal Pharmaceuticals LLCANDACurrent
65162-021Escitalopram OxalateEscitalopram OxalateAmneal Pharmaceuticals LLCANDACurrent
65162-021Escitalopram OxalateEscitalopram OxalateAmneal Pharmaceuticals LLCANDACurrent