Application 077734

Type
ANDA
Sponsor
CADILA

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077734-001ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11
A077734-002ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11
A077734-003ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077734-001AB
A077734-002AB
A077734-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1184e616aacf4f…
2026-08-18 06:07:402026-07A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077734-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077734-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077734-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A077734-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077734-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077734-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077734-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077734-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077734-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077734-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077734-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077734-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077734-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077734-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077734-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077734-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077734-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077734-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077734-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077734-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077734-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077734-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077734-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077734-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077734-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077734-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077734-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077734-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077734-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077734-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077734-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077734-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077734-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077734-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077734-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077734-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077734-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077734-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077734-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077734-001AB1301d65b070ca…

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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EscitalopramESCITALOPRAM OXALATEAmerican Health Packaging3019a647-9bcf-48cf-928c-0467f9b921a82025-03-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATENCS HealthCare of KY, LLC dba Vangard Labsb29ae169-d60b-464a-9763-f1d8d9e0598d2025-01-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
escitalopram oxalateESCITALOPRAM OXALATEBryant Ranch Prepack86cfcd96-6397-42ef-8a79-f62706f0aca62024-10-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram oxalate
generic name: ESCITALOPRAM OXALATE
escitalopram oxalateESCITALOPRAM OXALATEQuallent Pharmaceuticals Health LLCd8e22060-4d06-42bf-a881-caaf65ecc3e32024-10-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram oxalate
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATEAmneal Pharmaceuticals of New York LLC4f941d7a-5abb-4907-a7a1-480245deef872024-10-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATEAmneal Pharmaceuticals LLC8704d062-fa91-4224-9dec-41664d20ee6b2024-09-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATEA-S Medication Solutions76993020-6715-4090-847e-0fdcc5328f312024-07-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATEA-S Medication Solutionsc980262b-31f0-46df-902d-e593e1557fef2024-07-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATENorthStar RxLLC81840aec-96fd-4af2-bd10-3f38d068f39a2024-07-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
generic name: ESCITALOPRAM OXALATE
Escitalopram oxalateESCITALOPRAMExelan Pharmaceuticals Inc.8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd22024-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram oxalate
Escitalopram OxalateESCITALOPRAM OXALATEMacleods Pharmaceuticals Limited24b43cb4-1a26-44a2-b1d8-a40239eb5c7c2024-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEA-S Medication Solutionsb85ef018-0217-4ddf-885d-206acc0a5f842024-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEAdvanced Rx Pharmacy of Tennessee, LLC138f8703-2f13-6d07-e063-6394a90a44132024-03-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATENCS HealthCare of KY, LLC dba Vangard Labsac9ede0c-7912-4e7d-83b3-964feee612152023-07-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEA-S Medication Solutions10b25a10-c5e7-479b-a9f5-7eeafd8023232023-04-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
escitalopram oxalateESCITALOPRAM OXALATEProficient Rx LP8201a719-7837-45fb-b991-4fcdbf006d242023-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram oxalate
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEProficient Rx LP52df055d-b1c8-4de2-8545-ef08b5bf9c392022-08-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEProficient Rx LP2d0b4839-e4d1-4e0e-9dc0-ba821f2664722022-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
Escitalopram oxalateESCITALOPRAMAphena Pharma Solutions - Tennessee, LLC900b7a2f-23e7-4c78-bd6e-549bbe09883e2021-04-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram oxalate
escitalopram oxalateESCITALOPRAM OXALATEProficient Rx LPe773030f-d07d-4bb8-9dc9-6f649688346d2020-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram oxalate
generic name: ESCITALOPRAM OXALATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-102escitalopramescitalopramZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-102escitalopramescitalopramZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-103escitalopramescitalopramZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-103escitalopramescitalopramZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-104escitalopramescitalopramZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-104escitalopramescitalopramZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1145escitalopramescitalopramCadila Healthcare LimitedANDACurrent
70771-1145escitalopramescitalopramZydus Lifesciences LimitedANDACurrent
70771-1145escitalopramescitalopramCadila Healthcare LimitedANDACurrent
70771-1145escitalopramescitalopramCadila Healthcare LimitedANDACurrent
70771-1146escitalopramescitalopramCadila Healthcare LimitedANDACurrent
70771-1146escitalopramescitalopramZydus Lifesciences LimitedANDACurrent
70771-1146escitalopramescitalopramCadila Healthcare LimitedANDACurrent
70771-1146escitalopramescitalopramCadila Healthcare LimitedANDACurrent
70771-1147escitalopramescitalopramCadila Healthcare LimitedANDACurrent
70771-1147escitalopramescitalopramZydus Lifesciences LimitedANDACurrent
70771-1147escitalopramescitalopramCadila Healthcare LimitedANDACurrent
70771-1147escitalopramescitalopramCadila Healthcare LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9077ORIG2011-05-10