FDA.reportPublic FDA data

Application 078604

Type
ANDA
Sponsor
INVAGEN 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
31722-249EscitalopramEscitalopramCamber PharmaceuticalsANDACurrent
31722-250EscitalopramEscitalopramCamber PharmaceuticalsANDACurrent
31722-251EscitalopramEscitalopramCamber PharmaceuticalsANDACurrent
53217-167EscitalopramEscitalopramAidarex Pharmaceuticals LLCANDACurrent
64725-0250EscitalopramEscitalopramTYA PharmaceuticalsANDACurrent
64725-0251EscitalopramEscitalopramTYA PharmaceuticalsANDACurrent
68645-519Escitalopram OxalateEscitalopramLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-519Escitalopram OxalateEscitalopramLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-519Escitalopram OxalateEscitalopramLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-519Escitalopram OxalateEscitalopramLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-519Escitalopram OxalateEscitalopramLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-520Escitalopram OxalateEscitalopramLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-520Escitalopram OxalateEscitalopramLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-520Escitalopram OxalateEscitalopramLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-520Escitalopram OxalateEscitalopramLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-520Escitalopram OxalateEscitalopramLegacy Pharmaceutical Packaging, LLCANDACurrent
69097-847Escitalopram OxalateEscitalopramCipla USA Inc.ANDACurrent
69097-847Escitalopram OxalateEscitalopramCipla USA Inc.ANDACurrent
69097-847Escitalopram OxalateEscitalopramCipla USA Inc.ANDACurrent
69097-847Escitalopram OxalateEscitalopramCipla USA Inc.ANDACurrent
69097-847Escitalopram OxalateEscitalopramCipla USA Inc.ANDACurrent
69097-848Escitalopram OxalateEscitalopramCipla USA Inc.ANDACurrent
69097-848Escitalopram OxalateEscitalopramCipla USA Inc.ANDACurrent
69097-848Escitalopram OxalateEscitalopramCipla USA Inc.ANDACurrent
69097-848Escitalopram OxalateEscitalopramCipla USA Inc.ANDACurrent
69097-848Escitalopram OxalateEscitalopramCipla USA Inc.ANDACurrent
69097-849Escitalopram OxalateEscitalopramCipla USA Inc.ANDACurrent
69097-849Escitalopram OxalateEscitalopramCipla USA Inc.ANDACurrent
69097-849Escitalopram OxalateEscitalopramCipla USA Inc.ANDACurrent
69097-849Escitalopram OxalateEscitalopramCipla USA Inc.ANDACurrent
69097-849Escitalopram OxalateEscitalopramCipla USA Inc.ANDACurrent
70518-3151Escitalopram OxalateEscitalopramREMEDYREPACK INC.ANDACurrent
70518-3151Escitalopram OxalateEscitalopramREMEDYREPACK INC.ANDACurrent
71610-534Escitalopram oxalateescitalopramAphena Pharma Solutions - Tennessee, LLCANDACurrent
76282-249Escitalopram oxalateescitalopramExelan Pharmaceuticals Inc.ANDACurrent
76282-249Escitalopram oxalateescitalopramExelan Pharmaceuticals Inc.ANDACurrent
76282-249Escitalopram oxalateescitalopramExelan Pharmaceuticals Inc.ANDACurrent
76282-249Escitalopram oxalateescitalopramExelan Pharmaceuticals Inc.ANDACurrent
76282-250Escitalopram oxalateescitalopramExelan Pharmaceuticals Inc.ANDACurrent
76282-250Escitalopram oxalateescitalopramExelan Pharmaceuticals Inc.ANDACurrent
76282-250Escitalopram oxalateescitalopramExelan Pharmaceuticals Inc.ANDACurrent
76282-250Escitalopram oxalateescitalopramExelan Pharmaceuticals Inc.ANDACurrent
76282-251Escitalopram oxalateescitalopramExelan Pharmaceuticals Inc.ANDACurrent
76282-251Escitalopram oxalateescitalopramExelan Pharmaceuticals Inc.ANDACurrent
76282-251Escitalopram oxalateescitalopramExelan Pharmaceuticals Inc.ANDACurrent
76282-251Escitalopram oxalateescitalopramExelan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9172ORIG2011-05-10