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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020822-001CELEXACITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALABRLD2000-04-27
N020822-002CELEXACITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALABRLD1998-07-17
N020822-003CELEXACITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALABRLD, RS1998-07-17
N020822-004CELEXACITALOPRAM HYDROBROMIDEEQ 60MG BASETABLET / ORAL1998-07-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N020822-001AB
N020822-002AB
N020822-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020822-001CELEXAEQ 10MG BASETABLET / ORALABRLD2000-04-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020822-002CELEXAEQ 20MG BASETABLET / ORALABRLD1998-07-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020822-003CELEXAEQ 40MG BASETABLET / ORALABRLD, RS1998-07-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020822-004CELEXAEQ 60MG BASETABLET / ORAL1998-07-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020822-001CELEXAEQ 10MG BASETABLET / ORALABRLD2000-04-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020822-002CELEXAEQ 20MG BASETABLET / ORALABRLD1998-07-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020822-003CELEXAEQ 40MG BASETABLET / ORALABRLD, RS1998-07-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020822-004CELEXAEQ 60MG BASETABLET / ORAL1998-07-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020822-001CELEXAEQ 10MG BASETABLET / ORALABRLD2000-04-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020822-002CELEXAEQ 20MG BASETABLET / ORALABRLD1998-07-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020822-003CELEXAEQ 40MG BASETABLET / ORALABRLD, RS1998-07-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020822-004CELEXAEQ 60MG BASETABLET / ORAL1998-07-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020822-001CELEXAEQ 10MG BASETABLET / ORALABRLD2000-04-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020822-002CELEXAEQ 20MG BASETABLET / ORALABRLD1998-07-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020822-003CELEXAEQ 40MG BASETABLET / ORALABRLD, RS1998-07-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020822-004CELEXAEQ 60MG BASETABLET / ORAL1998-07-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020822-001CELEXAEQ 10MG BASETABLET / ORALABRLD2000-04-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020822-002CELEXAEQ 20MG BASETABLET / ORALABRLD1998-07-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020822-003CELEXAEQ 40MG BASETABLET / ORALABRLD, RS1998-07-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020822-004CELEXAEQ 60MG BASETABLET / ORAL1998-07-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020822-001CELEXAEQ 10MG BASETABLET / ORALABRLD2000-04-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020822-002CELEXAEQ 20MG BASETABLET / ORALABRLD1998-07-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020822-003CELEXAEQ 40MG BASETABLET / ORALABRLD, RS1998-07-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020822-004CELEXAEQ 60MG BASETABLET / ORAL1998-07-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020822-001CELEXAEQ 10MG BASETABLET / ORALABRLD2000-04-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020822-002CELEXAEQ 20MG BASETABLET / ORALABRLD1998-07-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020822-003CELEXAEQ 40MG BASETABLET / ORALABRLD, RS1998-07-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020822-004CELEXAEQ 60MG BASETABLET / ORAL1998-07-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020822-001CELEXAEQ 10MG BASETABLET / ORALABRLD2000-04-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020822-002CELEXAEQ 20MG BASETABLET / ORALABRLD1998-07-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020822-003CELEXAEQ 40MG BASETABLET / ORALABRLD, RS1998-07-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020822-004CELEXAEQ 60MG BASETABLET / ORAL1998-07-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020822-001CELEXAEQ 10MG BASETABLET / ORALABRLD2000-04-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020822-002CELEXAEQ 20MG BASETABLET / ORALABRLD1998-07-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020822-003CELEXAEQ 40MG BASETABLET / ORALABRLD, RS1998-07-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020822-004CELEXAEQ 60MG BASETABLET / ORAL1998-07-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020822-001CELEXAEQ 10MG BASETABLET / ORALABRLD2000-04-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N020822-002CELEXAEQ 20MG BASETABLET / ORALABRLD1998-07-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N020822-003CELEXAEQ 40MG BASETABLET / ORALABRLD, RS1998-07-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N020822-004CELEXAEQ 60MG BASETABLET / ORAL1998-07-17d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020822-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020822-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020822-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020822-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020822-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020822-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020822-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020822-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020822-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020822-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020822-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020822-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020822-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020822-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020822-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020822-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020822-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020822-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020822-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020822-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020822-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020822-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020822-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020822-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020822-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020822-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020822-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020822-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020822-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020822-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020822-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020822-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020822-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020822-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020822-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020822-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020822-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020822-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020822-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020822-001AB18072bd15b7f6…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelexaCITALOPRAMAllergan, Inc.4259d9b1-de34-43a4-85a8-41dd214e91772023-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020822
application number: NDA020822
ndc (product): 0456-4010
ndc (product): 0456-4020
ndc (product): 0456-4040

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

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