Application 077031

Type
ANDA
Sponsor
AUROBINDO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDETABLET;ORALEQ 10MG BASENoNo
002CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDETABLET;ORALEQ 20MG BASENoNo
003CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDETABLET;ORALEQ 40MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077031-001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28
A077031-002CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28
A077031-003CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077031-001AB
A077031-002AB
A077031-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-281e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077031-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077031-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077031-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077031-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077031-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077031-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077031-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077031-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077031-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077031-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077031-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077031-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077031-001AB11e350fbaab3a…

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CitalopramCITALOPRAM HYDROBROMIDEREMEDYREPACK INC.625a78b2-4751-4ca5-91b6-7c85fd9f8c2e2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDENorthwind Health Company, LLCd9cc1649-913d-832d-e053-2995a90a5f9a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDENorthwind Health Company, LLCd9ccb3fb-b607-9491-e053-2995a90a39c92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEQPharma, Inc.0a967468-3869-4c8c-849f-9fc3a8dcc4892025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEPD-Rx Pharmaceuticals, Inc.31a18cdf-b0aa-18f5-e054-00144ff8d46c2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.544ba802-a536-579a-e054-00144ff88e882025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEBryant Ranch Prepack0bc0e09e-0f1d-4d52-b8fe-3ef8a2e5ea522025-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEREMEDYREPACK INC.0109f365-bebd-4810-a56f-4451e10245db2025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEAdvanced Rx Pharmacy of Tennessee, LLCf8b06b55-f6a2-2438-e053-6394a90a530a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutions2500cc9d-a67d-46c5-9a76-99bc63959d672024-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsb244d4eb-8311-4663-8bca-dc08e88e5f5d2024-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEQUALLENT PHARMACEUTICALS HEALTH LLCe0822069-9672-4d4c-bc1a-8739b0dd045c2024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEAurobindo Pharma Limited2632b547-2e13-447f-ac85-c774e437d6a82024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsfc766b76-18c1-42cd-b276-f720f5821c112024-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsc6730edc-7226-4521-a04a-1bf296b01b8d2024-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDENCS HealthCare of KY, LLC dba Vangard Labsfd761647-e16b-45b3-a4bc-364de0ed70152023-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEProficient Rx LPf37cc307-8b7d-4e5c-8beb-cd8779bc86a72022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEAphena Pharma Solutions - Tennessee, LLC31ddd184-7560-473c-b674-5fa3187c55982020-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
ndc (product): 71610-413
CitalopramCITALOPRAM HYDROBROMIDEProficient Rx LP289c1d5e-902f-47db-85b8-5e1a55ec86842019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 93 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70934-304CitalopramCitalopram HydrobromideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-304CitalopramCitalopram HydrobromideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-304CitalopramCitalopram HydrobromideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-341CitalopramCitalopram HydrobromideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-341CitalopramCitalopram HydrobromideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-341CitalopramCitalopram HydrobromideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-431CitalopramCitalopram HydrobromideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-431CitalopramCitalopram HydrobromideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0573CitalopramCitalopram HydrobromideBryant Ranch PrepackANDACurrent
71335-0573CitalopramCitalopram HydrobromideBryant Ranch PrepackANDACurrent
71335-0573CitalopramCitalopram HydrobromideBryant Ranch PrepackANDACurrent
71335-0573CitalopramCitalopram HydrobromideBryant Ranch PrepackANDACurrent
71610-413CitalopramCitalopram HydrobromideAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23846ORIG2005-07-29
8994ORIG2004-10-29