FDA.reportPublic FDA data

Application 021323

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEXAPROESCITALOPRAM OXALATETABLET;ORALEQ 5MG BASEYesNo
002LEXAPROESCITALOPRAM OXALATETABLET;ORALEQ 10MG BASEYesNo
003LEXAPROESCITALOPRAM OXALATETABLET;ORALEQ 20MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-3855Escitalopram OxalateescitalopramMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-3856Escitalopram OxalateescitalopramMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-3857Escitalopram OxalateescitalopramMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0456-2005LexaproESCITALOPRAMAllergan, Inc.NDACurrent
0456-2005LexaproESCITALOPRAM OXALATEAllergan, Inc.NDACurrent
0456-2005LexaproESCITALOPRAM OXALATEAllergan, Inc.NDACurrent
0456-2005LexaproESCITALOPRAMAllergan, Inc.NDACurrent
0456-2005LexaproESCITALOPRAMAllergan, Inc.NDACurrent
0456-2005LexaproESCITALOPRAM OXALATEAllergan, Inc.NDACurrent
0456-2005LexaproESCITALOPRAMAllergan, Inc.NDACurrent
0456-2010LexaproESCITALOPRAMAllergan, Inc.NDACurrent
0456-2010LexaproESCITALOPRAMAllergan, Inc.NDACurrent
0456-2010LexaproESCITALOPRAM OXALATEAllergan, Inc.NDACurrent
0456-2010LexaproESCITALOPRAMAllergan, Inc.NDACurrent
0456-2010LexaproESCITALOPRAM OXALATEAllergan, Inc.NDACurrent
0456-2010LexaproESCITALOPRAM OXALATEAllergan, Inc.NDACurrent
0456-2010LexaproESCITALOPRAMAllergan, Inc.NDACurrent
0456-2020LexaproESCITALOPRAMAllergan, Inc.NDACurrent
0456-2020LexaproESCITALOPRAM OXALATEAllergan, Inc.NDACurrent
0456-2020LexaproESCITALOPRAM OXALATEAllergan, Inc.NDACurrent
0456-2020LexaproESCITALOPRAMAllergan, Inc.NDACurrent
0456-2020LexaproESCITALOPRAMAllergan, Inc.NDACurrent
0456-2020LexaproESCITALOPRAM OXALATEAllergan, Inc.NDACurrent
0456-2020LexaproESCITALOPRAMAllergan, Inc.NDACurrent
10544-968Escitalopram OxalateescitalopramBlenheim Pharmacal, Inc.NDA AUTHORIZED GENERICCurrent
10544-969Escitalopram OxalateescitalopramBlenheim Pharmacal, Inc.NDA AUTHORIZED GENERICCurrent
33261-686LexaproESCITALOPRAM OXALATEAidarex Pharmaceuticals LLCNDACurrent
33261-699LexaproESCITALOPRAM OXALATEAidarex Pharmaceuticals LLCNDACurrent
50436-9803LexaproESCITALOPRAM OXALATEUnit Dose ServicesNDACurrent
51079-543Escitalopram OxalateescitalopramMylan Institutional Inc.NDACurrent
51079-544Escitalopram OxalateescitalopramMylan Institutional Inc.NDACurrent
55154-5379Escitalopram OxalateescitalopramCardinal HealthNDACurrent
55154-5386Escitalopram OxalateescitalopramCardinal HealthNDACurrent
55289-768LexaproESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-768LexaproESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-768LexaproESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-768LexaproESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-768LexaproESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-828LexaproESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-828LexaproESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-828LexaproESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-828LexaproESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-828LexaproESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.NDACurrent
63629-2981LexaproESCITALOPRAM OXALATEBryant Ranch PrepackNDACurrent
63629-2981LexaproESCITALOPRAM OXALATEBryant Ranch PrepackNDACurrent
63629-2981LexaproESCITALOPRAM OXALATEBryant Ranch PrepackNDACurrent
67046-173Escitalopram OxalateescitalopramContract Pharmacy Services-PANDACurrent
70518-0972Escitalopram OxalateescitalopramREMEDYREPACK INC.NDACurrent
70518-0972Escitalopram OxalateescitalopramREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78267SUPPL 2024-04-25
78230SUPPL 2024-04-24
78199SUPPL 2024-04-22
75252SUPPL 2023-08-22
75183SUPPL 2023-08-21
75182SUPPL 2023-08-21
74255SUPPL 2023-05-15
74254SUPPL 2023-05-15
74239SUPPL 2023-05-15
68754SUPPL2021-09-24
68752SUPPL2021-09-24
68723SUPPL2021-09-22
64511SUPPL2020-09-04
64456SUPPL2020-09-01
57258SUPPL2019-01-18
57197SUPPL2019-01-14
46782SUPPL2017-01-11
46781SUPPL2017-01-11
46682SUPPL2017-01-06
36662SUPPL2014-11-04
27488SUPPL2014-11-03
36663SUPPL2014-07-21
5043SUPPL2014-07-10
5042SUPPL2012-12-05
36661SUPPL2012-12-03
42102SUPPL2012-01-27
21600SUPPL2012-01-27
15193SUPPL2011-05-16
5041SUPPL2011-05-16
27487SUPPL2011-03-16
15194SUPPL2011-03-11
36659SUPPL2009-03-25
36658SUPPL2009-03-25
27485SUPPL2009-03-24
5040SUPPL2009-03-24
36660SUPPL2009-02-04
27486SUPPL2009-02-03
27484SUPPL2008-10-21
36657SUPPL2008-09-19
27483SUPPL2008-09-19
27482SUPPL2007-08-07
15192SUPPL2007-08-03
21599SUPPL2007-07-06
21598SUPPL2007-07-06
23644ORIG2005-07-29
5039SUPPL2005-02-23
27480SUPPL2005-01-13
36655SUPPL2004-06-08
27481SUPPL2004-05-26
42101SUPPL2004-04-12
42100ORIG2004-04-12
36656SUPPL2003-12-22
27479SUPPL2003-12-22
15191SUPPL2003-12-22
5038SUPPL2003-12-22
27478SUPPL2002-08-29
15190ORIG2002-08-14
5037ORIG2002-08-14
54158SUPPL1900-01-01
54156SUPPL1900-01-01
53260ORIG1900-01-01
53259ORIG1900-01-01
53258ORIG1900-01-01