Application 090432

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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 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
A090432-001ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11
A090432-002ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11
A090432-003ESCITALOPRAM 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
A090432-001AB
A090432-002AB
A090432-003AB

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 06:07:402026-07A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-111e350fbaab3a…

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 06:07:402026-07A090432-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090432-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090432-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090432-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090432-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090432-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090432-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090432-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090432-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090432-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090432-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090432-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090432-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090432-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090432-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090432-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090432-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090432-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090432-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090432-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090432-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090432-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090432-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090432-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090432-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090432-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090432-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090432-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090432-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090432-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090432-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090432-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090432-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090432-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090432-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090432-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090432-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090432-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090432-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090432-001AB11e350fbaab3a…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EscitalopramESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.517a551a-6f60-4b8d-9341-63a41baff12d2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEBryant Ranch Prepackee5963ad-3b53-48e5-b7a9-b13af5740ef12026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATESt. Mary's Medical Park Pharmacy09945404-e4cf-6269-e063-6294a90a5b8d2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEAurobindo Pharma Limitedd5fbc8ce-bd41-4bd0-b413-0dea97e596c32026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
ndc (product): 65862-374
ndc (product): 65862-375
ndc (product): 65862-373
EscitalopramESCITALOPRAM OXALATEAsclemed USA, Inc.2957a003-7714-4e16-aeca-623fd6c5d7022026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATENorthwind Health Company, LLCf6ca64ec-68ff-e1ea-e053-6294a90ae0f82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEQPharma, Inc.85fbcce8-a870-4f04-8a0e-a12e46eed3cf2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
ndc (product): 42708-077
EscitalopramESCITALOPRAM OXALATEAmerican Health Packaging3019a647-9bcf-48cf-928c-0467f9b921a82025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
ndc (product): 68084-618
ndc (product): 68084-617
EscitalopramESCITALOPRAM OXALATENCS HealthCare of KY, LLC dba Vangard Labsb29ae169-d60b-464a-9763-f1d8d9e0598d2025-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEA-S Medication Solutionsb85ef018-0217-4ddf-885d-206acc0a5f842024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEAdvanced Rx Pharmacy of Tennessee, LLC138f8703-2f13-6d07-e063-6394a90a44132024-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATENCS HealthCare of KY, LLC dba Vangard Labsac9ede0c-7912-4e7d-83b3-964feee612152023-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEA-S Medication Solutions10b25a10-c5e7-479b-a9f5-7eeafd8023232023-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEProficient Rx LP52df055d-b1c8-4de2-8545-ef08b5bf9c392022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
ndc (product): 71205-193
EscitalopramESCITALOPRAM OXALATEProficient Rx LP2d0b4839-e4d1-4e0e-9dc0-ba821f2664722022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
ndc (product): 71205-168

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42708-077EscitalopramEscitalopram OxalateQPharma IncANDACurrent
42708-077EscitalopramEscitalopram OxalateQPharma IncANDACurrent
50090-5131EscitalopramEscitalopram OxalateA-S Medication SolutionsANDACurrent
50090-6025EscitalopramEscitalopram OxalateA-S Medication SolutionsANDACurrent
55154-6649EscitalopramEscitalopram OxalateCardinal HealthANDACurrent
55154-6649EscitalopramEscitalopram OxalateCardinal HealthANDACurrent
57237-092EscitalopramEscitalopram OxalateCitron Pharma LLCANDACurrent
57237-093EscitalopramEscitalopram OxalateCitron Pharma LLCANDACurrent
57237-094EscitalopramEscitalopram OxalateCitron Pharma LLCANDACurrent
65862-373EscitalopramEscitalopram OxalateAurobindo Pharma LimitedANDACurrent
65862-373EscitalopramEscitalopram OxalateAurobindo Pharma LimitedANDACurrent
65862-373EscitalopramEscitalopram OxalateAurobindo Pharma LimitedANDACurrent
65862-373EscitalopramEscitalopram OxalateAurobindo Pharma LimitedANDACurrent
65862-373EscitalopramEscitalopram OxalateAurobindo Pharma LimitedANDACurrent
65862-374EscitalopramEscitalopram OxalateAurobindo Pharma LimitedANDACurrent
65862-374EscitalopramEscitalopram OxalateAurobindo Pharma LimitedANDACurrent
65862-374EscitalopramEscitalopram OxalateAurobindo Pharma LimitedANDACurrent
65862-374EscitalopramEscitalopram OxalateAurobindo Pharma LimitedANDACurrent
65862-374EscitalopramEscitalopram OxalateAurobindo Pharma LimitedANDACurrent
65862-375EscitalopramEscitalopram OxalateAurobindo Pharma LimitedANDACurrent
65862-375EscitalopramEscitalopram OxalateAurobindo Pharma LimitedANDACurrent
65862-375EscitalopramEscitalopram OxalateAurobindo Pharma LimitedANDACurrent
65862-375EscitalopramEscitalopram OxalateAurobindo Pharma LimitedANDACurrent
65862-375EscitalopramEscitalopram OxalateAurobindo Pharma LimitedANDACurrent
68071-2597EscitalopramEscitalopram OxalateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4484EscitalopramEscitalopram OxalateNuCare Pharmaceuticals,Inc.ANDACurrent
68084-617EscitalopramEscitalopram OxalateAmerican Health PackagingANDACurrent
68084-617EscitalopramEscitalopram OxalateAmerican Health PackagingANDACurrent
68084-617EscitalopramEscitalopram OxalateAmerican Health PackagingANDACurrent
68084-617EscitalopramEscitalopram OxalateAmerican Health PackagingANDACurrent
68084-618EscitalopramEscitalopram OxalateAmerican Health PackagingANDACurrent
68084-618EscitalopramEscitalopram OxalateAmerican Health PackagingANDACurrent
68084-618EscitalopramEscitalopram OxalateAmerican Health PackagingANDACurrent
68084-618EscitalopramEscitalopram OxalateAmerican Health PackagingANDACurrent
68788-9456EscitalopramEscitalopram OxalatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9714EscitalopramEscitalopram OxalatePreferred Pharmaceuticals, Inc.ANDACurrent
70518-1103EscitalopramEscitalopram OxalateREMEDYREPACK INC.ANDACurrent
70518-1103EscitalopramEscitalopram OxalateREMEDYREPACK INC.ANDACurrent
71205-168EscitalopramEscitalopram OxalateProficient Rx LPANDACurrent
71205-168EscitalopramEscitalopram OxalateProficient Rx LPANDACurrent
71205-168EscitalopramEscitalopram OxalateProficient Rx LPANDACurrent
71205-168EscitalopramEscitalopram OxalateProficient Rx LPANDACurrent
71205-193EscitalopramEscitalopram OxalateProficient Rx LPANDACurrent
71205-193EscitalopramEscitalopram OxalateProficient Rx LPANDACurrent
71205-193EscitalopramEscitalopram OxalateProficient Rx LPANDACurrent
71205-193EscitalopramEscitalopram OxalateProficient Rx LPANDACurrent
71205-193EscitalopramEscitalopram OxalateProficient Rx LPANDACurrent
71335-0658EscitalopramEscitalopram OxalateBryant Ranch PrepackANDACurrent
71335-0658EscitalopramEscitalopram OxalateBryant Ranch PrepackANDACurrent
71335-0658EscitalopramEscitalopram OxalateBryant Ranch PrepackANDACurrent