Application 021365

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEXAPROESCITALOPRAM OXALATESOLUTION;ORALEQ 5MG BASE/5MLYesYes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021365-001LEXAPROESCITALOPRAM OXALATEEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-27

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N021365-001NPP2026-05-12

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-2784e616aacf4f…
2026-08-18 06:07:402026-07N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021365-001LEXAPROEQ 5MG BASE/5MLSOLUTION / ORALRLD2002-11-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021365-001LEXAPROEQ 5MG BASE/5MLSOLUTION / ORALRLD2002-11-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021365-001LEXAPROEQ 5MG BASE/5MLSOLUTION / ORALAARLD, RS2002-11-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / ORALRLD2002-11-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021365-001LEXAPROEQ 5MG BASE/5MLSOLUTION / ORALRLD2002-11-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N021365-001LEXAPROEQ 5MG BASE/5MLSOLUTION / ORALRLD2002-11-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021365-001LEXAPROEQ 5MG BASE/5MLSOLUTION / ORALRLD2002-11-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021365-001LEXAPROEQ 5MG BASE/5MLSOLUTION / ORALRLD2002-11-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021365-001LEXAPROEQ 5MG BASE/5MLSOLUTION / ORALAARLD, RS2002-11-273f01610625f2…
2019-09-15 20:21 UTC2019-09N021365-001LEXAPROEQ 5MG BASE/5MLSOLUTION / ORALAARLD, RS2002-11-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N021365-001LEXAPROEQ 5MG BASE/5MLSOLUTION / ORALAARLD, RS2002-11-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021365-001LEXAPROEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2002-11-27f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N021365-001AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021365-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09N021365-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021365-001AA1ea99ee380514…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N021365-001NPP2026-05-1284e616aacf4f…
2026-08-18 06:07:402026-07N021365-001NPP2026-05-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021365-001NPP2026-05-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021365-001NPP2026-05-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021365-001NPP2026-05-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021365-001NPP2026-05-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021365-001NPP2026-05-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021365-001NPP2026-05-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021365-001NPP2026-05-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021365-001NPP2026-05-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021365-001NPP2026-05-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021365-001NPP2026-05-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021365-001NPP2026-05-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021365-001NPP2026-05-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021365-001NPP2026-05-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021365-001NPP2026-05-128072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021365-001NPP2026-05-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021365-001NPP2026-05-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021365-001NPP2026-05-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021365-001NPP2026-05-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021365-001NPP2026-05-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021365-001NPP2026-05-12a67488948f0b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021365-001NPP2026-05-12a50c72e98297…

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 2 · 34 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 reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEJubilant Cadista Pharmaceuticals Inc.2db02476-325f-ee47-a7e5-b5aed56c364c2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEBryant Ranch Prepackee5963ad-3b53-48e5-b7a9-b13af5740ef12026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATESt. Mary's Medical Park Pharmacy09945404-e4cf-6269-e063-6294a90a5b8d2026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATECamber Pharmaceuticals, Inc.82d793ee-4039-45fc-ac83-4bd5235f00aa2026-05-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATERising Pharma Holdings, Inc.79fddc2d-2dc2-444f-8fd3-0337090ee7442026-05-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
escitalopram oxalateESCITALOPRAM OXALATEBryant Ranch Prepacka3a158a3-43ee-4b08-8171-e8c0d6ed0e662026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEAurobindo Pharma Limitedd5fbc8ce-bd41-4bd0-b413-0dea97e596c32026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATEAurobindo Pharma Limitedba60c357-8e61-4a3d-b1dc-25602dbbfc2a2026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
escitalopram oxalateESCITALOPRAM OXALATEPreferred Pharmaceuticals Inc.7d924d16-8a10-411d-be57-97c450f56de72026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEAsclemed USA, Inc.2957a003-7714-4e16-aeca-623fd6c5d7022026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATENorthwind Health Company, LLCf6ca64ec-68ff-e1ea-e053-6294a90ae0f82026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEQPharma, Inc.85fbcce8-a870-4f04-8a0e-a12e46eed3cf2025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
escitalopram oxalateESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.b7670e51-8f44-4f64-b110-3f2f431a40322025-10-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATESun Pharmaceutical Industries, Inc.c871d3fe-5ca2-410c-976d-9ec4b72c878f2025-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
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
generic name: ESCITALOPRAM OXALATE
escitalopram oxalateESCITALOPRAM OXALATEQuallent Pharmaceuticals Health LLCd8e22060-4d06-42bf-a881-caaf65ecc3e32024-10-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATEAmneal Pharmaceuticals of New York LLC4f941d7a-5abb-4907-a7a1-480245deef872024-10-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78264SUPPL 2024-04-25
78227SUPPL 2024-04-24
78198SUPPL 2024-04-22
75253SUPPL 2023-08-22
75185SUPPL 2023-08-21
74256SUPPL 2023-05-15
74240SUPPL 2023-05-15
68750SUPPL2021-09-24
68748SUPPL2021-09-24
68722SUPPL2021-09-22
64512SUPPL2020-09-04
64457SUPPL2020-09-01
57259SUPPL2019-01-18
57198SUPPL2019-01-14
46784SUPPL2017-01-11
46783SUPPL2017-01-11
46681SUPPL2017-01-06
36768SUPPL2014-11-04
5189SUPPL2014-11-03
36769SUPPL2014-07-21
27600SUPPL2014-07-10
27599SUPPL2012-12-05
36767SUPPL2012-12-03
15307SUPPL2011-05-16
5187SUPPL2011-05-16
5188SUPPL2011-03-16
15308SUPPL2011-03-11
36765SUPPL2009-03-25
15306SUPPL2009-03-25
27598SUPPL2009-03-24
5185SUPPL2009-03-24
36766SUPPL2009-02-04
5186SUPPL2009-02-03
5184SUPPL2008-10-21
36764SUPPL2008-09-19
5183SUPPL2008-09-19
21620SUPPL2007-07-06
21619SUPPL2007-07-06
23650ORIG2005-07-29
5182SUPPL2005-02-23
5180SUPPL2005-01-13
42121ORIG2004-06-29
5181SUPPL2004-05-26
15305SUPPL2003-12-22
15304SUPPL2003-12-22
5179SUPPL2003-12-22
5178SUPPL2003-12-22
36763ORIG2002-11-27
5177ORIG2002-11-27