Application 020822

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CELEXACITALOPRAM HYDROBROMIDETABLET;ORALEQ 10MG BASEYesNo
002CELEXACITALOPRAM HYDROBROMIDETABLET;ORALEQ 20MG BASEYesNo
003CELEXACITALOPRAM HYDROBROMIDETABLET;ORALEQ 40MG BASEYesYes
004CELEXACITALOPRAM HYDROBROMIDETABLET;ORALEQ 60MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0456-4010CelexacitalopramAllergan, Inc.NDACurrent
0456-4010CelexacitalopramAllergan, Inc.NDACurrent
0456-4010CelexacitalopramAllergan, Inc.NDACurrent
0456-4010CelexacitalopramAllergan, Inc.NDACurrent
0456-4010CelexacitalopramAllergan, Inc.NDACurrent
0456-4020CelexacitalopramAllergan, Inc.NDACurrent
0456-4020CelexacitalopramAllergan, Inc.NDACurrent
0456-4020CelexacitalopramAllergan, Inc.NDACurrent
0456-4020CelexacitalopramAllergan, Inc.NDACurrent
0456-4020CelexacitalopramAllergan, Inc.NDACurrent
0456-4040CelexacitalopramAllergan, Inc.NDACurrent
0456-4040CelexacitalopramAllergan, Inc.NDACurrent
0456-4040CelexacitalopramAllergan, Inc.NDACurrent
0456-4040CelexacitalopramAllergan, Inc.NDACurrent
0456-4040CelexacitalopramAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78263SUPPL 2024-04-25
78226SUPPL 2024-04-24
78197SUPPL 2024-04-22
75265SUPPL 2023-08-22
75142SUPPL 2023-08-21
70128SUPPL2022-02-08
70127SUPPL2022-02-08
70107SUPPL2022-02-08
68774SUPPL2021-09-24
68773SUPPL2021-09-24
68721SUPPL2021-09-22
57257SUPPL2019-01-18
57196SUPPL2019-01-14
46780SUPPL2017-01-11
46779SUPPL2017-01-11
46683SUPPL2017-01-06
13490SUPPL2014-07-21
25919SUPPL2014-07-10
35416SUPPL2014-05-12
25918SUPPL2014-04-17
20979SUPPL2013-09-11
3424SUPPL2012-12-05
13489SUPPL2012-12-03
25917SUPPL2012-03-29
35415SUPPL2012-03-28
41722SUPPL2011-10-11
20978SUPPL2011-10-11
25916SUPPL2011-08-17
3423SUPPL2011-08-17
35414SUPPL2011-08-16
13488SUPPL2011-08-16
13487SUPPL2009-02-04
3422SUPPL2009-02-03
13486SUPPL2008-09-19
3421SUPPL2008-09-19
3420SUPPL2007-08-07
13485SUPPL2007-08-03
20977SUPPL2006-05-18
13484SUPPL2005-02-28
3419SUPPL2005-02-23
3418SUPPL2004-05-26
25915SUPPL2004-04-20
25914SUPPL2002-11-19
35413ORIG1998-07-17
20976ORIG1998-07-17
3417ORIG1998-07-17
51824ORIG1900-01-01
51823ORIG1900-01-01
51822ORIG1900-01-01