Application 021365
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEXAPRO | ESCITALOPRAM OXALATE | SOLUTION;ORAL | EQ 5MG BASE/5ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021365-001 | LEXAPRO | ESCITALOPRAM OXALATE | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N021365-001 | NPP | 2026-05-12 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML | SOLUTION / ORAL | RLD | 2002-11-27 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML | SOLUTION / ORAL | RLD | 2002-11-27 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML | SOLUTION / ORAL | AA | RLD, RS | 2002-11-27 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML | SOLUTION / ORAL | RLD | 2002-11-27 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML | SOLUTION / ORAL | RLD | 2002-11-27 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML | SOLUTION / ORAL | RLD | 2002-11-27 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML | SOLUTION / ORAL | RLD | 2002-11-27 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML | SOLUTION / ORAL | AA | RLD, RS | 2002-11-27 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML | SOLUTION / ORAL | AA | RLD, RS | 2002-11-27 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML | SOLUTION / ORAL | AA | RLD, RS | 2002-11-27 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021365-001 | LEXAPRO | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2002-11-27 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021365-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N021365-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021365-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021365-001 | AA | 1 | ea99ee380514… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021365-001 | NPP | 2026-05-12 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021365-001 | NPP | 2026-05-12 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021365-001 | NPP | 2026-05-12 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021365-001 | NPP | 2026-05-12 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021365-001 | NPP | 2026-05-12 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021365-001 | NPP | 2026-05-12 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021365-001 | NPP | 2026-05-12 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021365-001 | NPP | 2026-05-12 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021365-001 | NPP | 2026-05-12 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021365-001 | NPP | 2026-05-12 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021365-001 | NPP | 2026-05-12 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021365-001 | NPP | 2026-05-12 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021365-001 | NPP | 2026-05-12 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021365-001 | NPP | 2026-05-12 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021365-001 | NPP | 2026-05-12 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021365-001 | NPP | 2026-05-12 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021365-001 | NPP | 2026-05-12 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021365-001 | NPP | 2026-05-12 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021365-001 | NPP | 2026-05-12 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021365-001 | NPP | 2026-05-12 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021365-001 | NPP | 2026-05-12 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021365-001 | NPP | 2026-05-12 | a67488948f0b… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021365-001 | NPP | 2026-05-12 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Escitalopram Oxalate | ESCITALOPRAM OXALATE | Amneal Pharmaceuticals LLC | 8704d062-fa91-4224-9dec-41664d20ee6b | 2024-09-26 | Boxed warning, Warnings, Adverse reactions | ESCITALOPRAM OXALATE |
| Escitalopram Oxalate | ESCITALOPRAM OXALATE | A-S Medication Solutions | 76993020-6715-4090-847e-0fdcc5328f31 | 2024-07-31 | Boxed warning, Warnings, Adverse reactions | ESCITALOPRAM OXALATE |
| Escitalopram Oxalate | ESCITALOPRAM OXALATE | A-S Medication Solutions | c980262b-31f0-46df-902d-e593e1557fef | 2024-07-31 | Boxed warning, Warnings, Adverse reactions | ESCITALOPRAM OXALATE |
| Escitalopram Oxalate | ESCITALOPRAM OXALATE | NorthStar RxLLC | 81840aec-96fd-4af2-bd10-3f38d068f39a | 2024-07-05 | Boxed warning, Warnings, Adverse reactions | ESCITALOPRAM OXALATE |
| Escitalopram Oxalate | ESCITALOPRAM OXALATE | Macleods Pharmaceuticals Limited | 24b43cb4-1a26-44a2-b1d8-a40239eb5c7c | 2024-05-22 | Boxed warning, Warnings, Adverse reactions | ESCITALOPRAM OXALATE |
| Escitalopram | ESCITALOPRAM OXALATE | A-S Medication Solutions | b85ef018-0217-4ddf-885d-206acc0a5f84 | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | ESCITALOPRAM OXALATE |
| Escitalopram | ESCITALOPRAM OXALATE | Advanced Rx Pharmacy of Tennessee, LLC | 138f8703-2f13-6d07-e063-6394a90a4413 | 2024-03-19 | Boxed warning, Warnings, Adverse reactions | ESCITALOPRAM OXALATE |
| Lexapro | ESCITALOPRAM | Allergan, Inc. | 13bb8267-1cab-43e5-acae-55a4d957630a | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | Lexapro |
| Escitalopram | ESCITALOPRAM OXALATE | NCS HealthCare of KY, LLC dba Vangard Labs | ac9ede0c-7912-4e7d-83b3-964feee61215 | 2023-07-20 | Boxed warning, Warnings, Adverse reactions | ESCITALOPRAM OXALATE |
| Escitalopram | ESCITALOPRAM OXALATE | A-S Medication Solutions | 10b25a10-c5e7-479b-a9f5-7eeafd802323 | 2023-04-16 | Boxed warning, Warnings, Adverse reactions | ESCITALOPRAM OXALATE |
| escitalopram oxalate | ESCITALOPRAM OXALATE | Proficient Rx LP | 8201a719-7837-45fb-b991-4fcdbf006d24 | 2023-04-01 | Boxed warning, Warnings, Adverse reactions | ESCITALOPRAM OXALATE |
| Escitalopram | ESCITALOPRAM OXALATE | Proficient Rx LP | 52df055d-b1c8-4de2-8545-ef08b5bf9c39 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | ESCITALOPRAM OXALATE |
| Escitalopram | ESCITALOPRAM OXALATE | Proficient Rx LP | 2d0b4839-e4d1-4e0e-9dc0-ba821f266472 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | ESCITALOPRAM OXALATE |
| escitalopram oxalate | ESCITALOPRAM OXALATE | Proficient Rx LP | e773030f-d07d-4bb8-9dc9-6f649688346d | 2020-03-01 | Boxed warning, Warnings, Adverse reactions | ESCITALOPRAM OXALATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78264 | SUPPL | 2024-04-25 |
| 78227 | SUPPL | 2024-04-24 |
| 78198 | SUPPL | 2024-04-22 |
| 75253 | SUPPL | 2023-08-22 |
| 75185 | SUPPL | 2023-08-21 |
| 74256 | SUPPL | 2023-05-15 |
| 74240 | SUPPL | 2023-05-15 |
| 68750 | SUPPL | 2021-09-24 |
| 68748 | SUPPL | 2021-09-24 |
| 68722 | SUPPL | 2021-09-22 |
| 64512 | SUPPL | 2020-09-04 |
| 64457 | SUPPL | 2020-09-01 |
| 57259 | SUPPL | 2019-01-18 |
| 57198 | SUPPL | 2019-01-14 |
| 46784 | SUPPL | 2017-01-11 |
| 46783 | SUPPL | 2017-01-11 |
| 46681 | SUPPL | 2017-01-06 |
| 36768 | SUPPL | 2014-11-04 |
| 5189 | SUPPL | 2014-11-03 |
| 36769 | SUPPL | 2014-07-21 |
| 27600 | SUPPL | 2014-07-10 |
| 27599 | SUPPL | 2012-12-05 |
| 36767 | SUPPL | 2012-12-03 |
| 15307 | SUPPL | 2011-05-16 |
| 5187 | SUPPL | 2011-05-16 |
| 5188 | SUPPL | 2011-03-16 |
| 15308 | SUPPL | 2011-03-11 |
| 36765 | SUPPL | 2009-03-25 |
| 15306 | SUPPL | 2009-03-25 |
| 27598 | SUPPL | 2009-03-24 |
| 5185 | SUPPL | 2009-03-24 |
| 36766 | SUPPL | 2009-02-04 |
| 5186 | SUPPL | 2009-02-03 |
| 5184 | SUPPL | 2008-10-21 |
| 36764 | SUPPL | 2008-09-19 |
| 5183 | SUPPL | 2008-09-19 |
| 21620 | SUPPL | 2007-07-06 |
| 21619 | SUPPL | 2007-07-06 |
| 23650 | ORIG | 2005-07-29 |
| 5182 | SUPPL | 2005-02-23 |
| 5180 | SUPPL | 2005-01-13 |
| 42121 | ORIG | 2004-06-29 |
| 5181 | SUPPL | 2004-05-26 |
| 15305 | SUPPL | 2003-12-22 |
| 15304 | SUPPL | 2003-12-22 |
| 5179 | SUPPL | 2003-12-22 |
| 5178 | SUPPL | 2003-12-22 |
| 36763 | ORIG | 2002-11-27 |
| 5177 | ORIG | 2002-11-27 |