FDA.reportPublic FDA data

Application 202221

Type
ANDA
Sponsor
HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESCITALOPRAM OXALATEESCITALOPRAM OXALATESOLUTION;ORALEQ 5MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-569Escitalopram OxalateEscitalopram OxalateCamber Pharmaceuticals, Inc.ANDACurrent
31722-569Escitalopram OxalateEscitalopram OxalateCamber Pharmaceuticals, Inc.ANDACurrent
31722-569Escitalopram OxalateEscitalopram OxalateCamber Pharmaceuticals, Inc.ANDACurrent
31722-569Escitalopram OxalateEscitalopram OxalateCamber Pharmaceuticals, Inc.ANDACurrent