Home Applications 021323 Application 021323
Type NDA
Sponsor ALLERGAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LEXAPRO ESCITALOPRAM OXALATE TABLET;ORAL EQ 5MG BASE Yes No 002 LEXAPRO ESCITALOPRAM OXALATE TABLET;ORAL EQ 10MG BASE Yes No 003 LEXAPRO ESCITALOPRAM OXALATE TABLET;ORAL EQ 20MG BASE Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021323-001 LEXAPRO ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 N021323-002 LEXAPRO ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 N021323-003 LEXAPRO ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N021323-001 NPP 2026-05-12 N021323-002 NPP 2026-05-12 N021323-003 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.
Product history page 1 of 4 · 126 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 252 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-001 6916941 2022-08-12 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-001 7420069 2022-08-12 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-001 6916941*PED 2023-02-12 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-001 7420069*PED 2023-02-12 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-002 6916941 2022-08-12 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-002 7420069 2022-08-12 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-002 6916941*PED 2023-02-12 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-002 7420069*PED 2023-02-12 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-003 6916941 2022-08-12 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-003 7420069 2022-08-12 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-003 6916941*PED 2023-02-12 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-003 7420069*PED 2023-02-12 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021323-001 6916941 2022-08-12 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-001 7420069 2022-08-12 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-001 6916941*PED 2023-02-12 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-001 7420069*PED 2023-02-12 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-002 6916941 2022-08-12 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-002 7420069 2022-08-12 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-002 6916941*PED 2023-02-12 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-002 7420069*PED 2023-02-12 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-003 6916941 2022-08-12 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-003 7420069 2022-08-12 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-003 6916941*PED 2023-02-12 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-003 7420069*PED 2023-02-12 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021323-001 6916941 2022-08-12 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-001 7420069 2022-08-12 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-001 6916941*PED 2023-02-12 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-001 7420069*PED 2023-02-12 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-002 6916941 2022-08-12 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-002 7420069 2022-08-12 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-002 6916941*PED 2023-02-12 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-002 7420069*PED 2023-02-12 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-003 6916941 2022-08-12 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-003 7420069 2022-08-12 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-003 6916941*PED 2023-02-12 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-003 7420069*PED 2023-02-12 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021323-001 6916941 2022-08-12 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021323-001 7420069 2022-08-12 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021323-001 6916941*PED 2023-02-12 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021323-001 7420069*PED 2023-02-12 Pediatric extension 74a2ff9319b5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 66 observed states.
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 49 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-3855 Escitalopram Oxalate escitalopram Mylan Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 0378-3856 Escitalopram Oxalate escitalopram Mylan Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 0378-3857 Escitalopram Oxalate escitalopram Mylan Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 0456-2005 Lexapro ESCITALOPRAM Allergan, Inc. NDA Current 0456-2005 Lexapro ESCITALOPRAM OXALATE Allergan, Inc. NDA Current 0456-2005 Lexapro ESCITALOPRAM OXALATE Allergan, Inc. NDA Current 0456-2005 Lexapro ESCITALOPRAM Allergan, Inc. NDA Current 0456-2005 Lexapro ESCITALOPRAM Allergan, Inc. NDA Current 0456-2005 Lexapro ESCITALOPRAM OXALATE Allergan, Inc. NDA Current 0456-2005 Lexapro ESCITALOPRAM Allergan, Inc. NDA Current 0456-2010 Lexapro ESCITALOPRAM Allergan, Inc. NDA Current 0456-2010 Lexapro ESCITALOPRAM OXALATE Allergan, Inc. NDA Current 0456-2010 Lexapro ESCITALOPRAM OXALATE Allergan, Inc. NDA Current 0456-2010 Lexapro ESCITALOPRAM Allergan, Inc. NDA Current 0456-2010 Lexapro ESCITALOPRAM Allergan, Inc. NDA Current 0456-2010 Lexapro ESCITALOPRAM OXALATE Allergan, Inc. NDA Current 0456-2010 Lexapro ESCITALOPRAM Allergan, Inc. NDA Current 0456-2020 Lexapro ESCITALOPRAM Allergan, Inc. NDA Current 0456-2020 Lexapro ESCITALOPRAM OXALATE Allergan, Inc. NDA Current 0456-2020 Lexapro ESCITALOPRAM OXALATE Allergan, Inc. NDA Current 0456-2020 Lexapro ESCITALOPRAM Allergan, Inc. NDA Current 0456-2020 Lexapro ESCITALOPRAM Allergan, Inc. NDA Current 0456-2020 Lexapro ESCITALOPRAM OXALATE Allergan, Inc. NDA Current 0456-2020 Lexapro ESCITALOPRAM Allergan, Inc. NDA Current 10544-968 Escitalopram Oxalate escitalopram Blenheim Pharmacal, Inc. NDA AUTHORIZED GENERIC Current 10544-969 Escitalopram Oxalate escitalopram Blenheim Pharmacal, Inc. NDA AUTHORIZED GENERIC Current 33261-686 Lexapro ESCITALOPRAM OXALATE Aidarex Pharmaceuticals LLC NDA Current 33261-699 Lexapro ESCITALOPRAM OXALATE Aidarex Pharmaceuticals LLC NDA Current 50436-9803 Lexapro ESCITALOPRAM OXALATE Unit Dose Services NDA Current 51079-543 Escitalopram Oxalate escitalopram Mylan Institutional Inc. NDA Current 51079-544 Escitalopram Oxalate escitalopram Mylan Institutional Inc. NDA Current 55154-5379 Escitalopram Oxalate escitalopram Cardinal Health NDA Current 55154-5386 Escitalopram Oxalate escitalopram Cardinal Health NDA Current 55289-768 Lexapro ESCITALOPRAM OXALATE PD-Rx Pharmaceuticals, Inc. NDA Current 55289-768 Lexapro ESCITALOPRAM OXALATE PD-Rx Pharmaceuticals, Inc. NDA Current 55289-768 Lexapro ESCITALOPRAM OXALATE PD-Rx Pharmaceuticals, Inc. NDA Current 55289-768 Lexapro ESCITALOPRAM OXALATE PD-Rx Pharmaceuticals, Inc. NDA Current 55289-768 Lexapro ESCITALOPRAM OXALATE PD-Rx Pharmaceuticals, Inc. NDA Current 55289-828 Lexapro ESCITALOPRAM OXALATE PD-Rx Pharmaceuticals, Inc. NDA Current 55289-828 Lexapro ESCITALOPRAM OXALATE PD-Rx Pharmaceuticals, Inc. NDA Current 55289-828 Lexapro ESCITALOPRAM OXALATE PD-Rx Pharmaceuticals, Inc. NDA Current 55289-828 Lexapro ESCITALOPRAM OXALATE PD-Rx Pharmaceuticals, Inc. NDA Current 55289-828 Lexapro ESCITALOPRAM OXALATE PD-Rx Pharmaceuticals, Inc. NDA Current 63629-2981 Lexapro ESCITALOPRAM OXALATE Bryant Ranch Prepack NDA Current 63629-2981 Lexapro ESCITALOPRAM OXALATE Bryant Ranch Prepack NDA Current 63629-2981 Lexapro ESCITALOPRAM OXALATE Bryant Ranch Prepack NDA Current 67046-173 Escitalopram Oxalate escitalopram Contract Pharmacy Services-PA NDA Current 70518-0972 Escitalopram Oxalate escitalopram REMEDYREPACK INC. NDA Current 70518-0972 Escitalopram Oxalate escitalopram REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current