Application 202227

Type
ANDA
Sponsor
AMNEAL PHARMS

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
65162-705Escitalopram OxalateEscitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-705Escitalopram OxalateEscitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-705Escitalopram OxalateEscitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-705Escitalopram OxalateEscitalopramAmneal Pharmaceuticals LLCANDACurrent
65162-705Escitalopram OxalateEscitalopramAmneal Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32208ORIG2012-03-16