Home Applications 022416 Application 022416
Type NDA
Sponsor SUNOVION PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 APTIOM ESLICARBAZEPINE ACETATE TABLET;ORAL 200MG Yes No 002 APTIOM ESLICARBAZEPINE ACETATE TABLET;ORAL 400MG Yes No 003 APTIOM ESLICARBAZEPINE ACETATE TABLET;ORAL 600MG Yes No 004 APTIOM ESLICARBAZEPINE ACETATE TABLET;ORAL 800MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022416-001 APTIOM ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB RLD 2013-11-08 N022416-002 APTIOM ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB RLD 2013-11-08 N022416-003 APTIOM ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB RLD 2013-11-08 N022416-004 APTIOM ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB RLD, RS 2013-11-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 32 matching rows.
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 5 · 164 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 2026-02-19 14:30 UTC 2026-02 N022416-001 APTIOM 200MG TABLET / ORAL AB RLD 2013-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-002 APTIOM 400MG TABLET / ORAL AB RLD 2013-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-003 APTIOM 600MG TABLET / ORAL AB RLD 2013-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-004 APTIOM 800MG TABLET / ORAL AB RLD, RS 2013-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022416-001 APTIOM 200MG TABLET / ORAL AB RLD 2013-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022416-002 APTIOM 400MG TABLET / ORAL AB RLD 2013-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022416-003 APTIOM 600MG TABLET / ORAL AB RLD 2013-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022416-004 APTIOM 800MG TABLET / ORAL AB RLD, RS 2013-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022416-001 APTIOM 200MG TABLET / ORAL AB RLD 2013-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022416-002 APTIOM 400MG TABLET / ORAL AB RLD 2013-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022416-003 APTIOM 600MG TABLET / ORAL AB RLD 2013-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022416-004 APTIOM 800MG TABLET / ORAL AB RLD, RS 2013-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022416-001 APTIOM 200MG TABLET / ORAL AB RLD 2013-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022416-002 APTIOM 400MG TABLET / ORAL AB RLD 2013-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022416-003 APTIOM 600MG TABLET / ORAL AB RLD 2013-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022416-004 APTIOM 800MG TABLET / ORAL AB RLD, RS 2013-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022416-001 APTIOM 200MG TABLET / ORAL AB RLD 2013-11-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022416-002 APTIOM 400MG TABLET / ORAL AB RLD 2013-11-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022416-003 APTIOM 600MG TABLET / ORAL AB RLD 2013-11-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022416-004 APTIOM 800MG TABLET / ORAL AB RLD, RS 2013-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022416-001 APTIOM 200MG TABLET / ORAL AB RLD 2013-11-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022416-002 APTIOM 400MG TABLET / ORAL AB RLD 2013-11-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022416-003 APTIOM 600MG TABLET / ORAL AB RLD 2013-11-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022416-004 APTIOM 800MG TABLET / ORAL AB RLD, RS 2013-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022416-001 APTIOM 200MG TABLET / ORAL AB RLD 2013-11-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022416-002 APTIOM 400MG TABLET / ORAL AB RLD 2013-11-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022416-003 APTIOM 600MG TABLET / ORAL AB RLD 2013-11-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022416-004 APTIOM 800MG TABLET / ORAL AB RLD, RS 2013-11-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022416-001 APTIOM 200MG TABLET / ORAL AB RLD 2013-11-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022416-002 APTIOM 400MG TABLET / ORAL AB RLD 2013-11-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022416-003 APTIOM 600MG TABLET / ORAL AB RLD 2013-11-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022416-004 APTIOM 800MG TABLET / ORAL AB RLD, RS 2013-11-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022416-001 APTIOM 200MG TABLET / ORAL AB RLD 2013-11-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022416-002 APTIOM 400MG TABLET / ORAL AB RLD 2013-11-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022416-003 APTIOM 600MG TABLET / ORAL AB RLD 2013-11-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022416-004 APTIOM 800MG TABLET / ORAL AB RLD, RS 2013-11-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022416-001 APTIOM 200MG TABLET / ORAL AB RLD 2013-11-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022416-002 APTIOM 400MG TABLET / ORAL AB RLD 2013-11-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022416-003 APTIOM 600MG TABLET / ORAL AB RLD 2013-11-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022416-004 APTIOM 800MG TABLET / ORAL AB RLD, RS 2013-11-08 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Observed Orange Book patent history# Patent history page 1 of 56 · 2,232 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022416-001 9206135 2026-04-21 Drug substance 2016-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-001 9643929 2026-04-21 Drug product 2017-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-001 9763954 2028-09-13 U-2123 2017-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-001 10912781 2028-10-23 Drug product 2021-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-001 9566244 2028-10-23 Drug product 2017-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-001 8372431 2030-04-17 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-001 9750747 2032-08-24 U-2041 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-001 9750747 2032-08-24 U-2121 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-002 9206135 2026-04-21 Drug substance 2016-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-002 9643929 2026-04-21 Drug product 2017-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-002 9763954 2028-09-13 U-2123 2017-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-002 10912781 2028-10-23 Drug product 2021-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-002 9566244 2028-10-23 Drug product 2017-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-002 8372431 2030-04-17 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-002 9750747 2032-08-24 U-2121 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-002 9750747 2032-08-24 U-2041 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-003 9206135 2026-04-21 Drug substance 2016-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-003 9643929 2026-04-21 Drug product 2017-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-003 9763954 2028-09-13 U-2123 2017-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-003 10912781 2028-10-23 Drug product 2021-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-003 9566244 2028-10-23 Drug product 2017-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-003 8372431 2030-04-17 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-003 9750747 2032-08-24 U-2121 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-003 9750747 2032-08-24 U-2041 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-004 9206135 2026-04-21 Drug substance 2016-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-004 9643929 2026-04-21 Drug product 2017-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-004 9763954 2028-09-13 U-2123 2017-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-004 10912781 2028-10-23 Drug product 2021-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-004 9566244 2028-10-23 Drug product 2017-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-004 8372431 2030-04-17 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-004 9750747 2032-08-24 U-2041 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022416-004 9750747 2032-08-24 U-2121 2017-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022416-001 10675287 2025-05-06 U-2831 2020-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022416-001 10675287 2025-05-06 U-2041 2020-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022416-001 10695354 2025-05-06 U-2831 2020-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022416-001 10695354 2025-05-06 U-2501 2020-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022416-001 10702536 2025-05-06 U-2501 2020-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022416-001 11364247 2025-05-06 U-2501 2022-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022416-001 11364247 2025-05-06 U-2831 2022-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022416-001 9206135 2026-04-21 Drug substance 2016-05-20 31067a03dcf5…
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 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63402-202 Aptiom ESLICARBAZEPINE ACETATE Sunovion Pharmaceuticals Inc. NDA Current 63402-202 Aptiom ESLICARBAZEPINE ACETATE Sunovion Pharmaceuticals NDA Current 63402-202 Aptiom ESLICARBAZEPINE ACETATE Sunovion Pharmaceuticals Inc. NDA Current 63402-204 Aptiom ESLICARBAZEPINE ACETATE Sunovion Pharmaceuticals Inc. NDA Current 63402-204 Aptiom ESLICARBAZEPINE ACETATE Sunovion Pharmaceuticals NDA Current 63402-204 Aptiom ESLICARBAZEPINE ACETATE Sunovion Pharmaceuticals Inc. NDA Current 63402-206 Aptiom ESLICARBAZEPINE ACETATE Sunovion Pharmaceuticals Inc. NDA Current 63402-206 Aptiom ESLICARBAZEPINE ACETATE Sunovion Pharmaceuticals NDA Current 63402-206 Aptiom ESLICARBAZEPINE ACETATE Sunovion Pharmaceuticals Inc. NDA Current 63402-208 Aptiom ESLICARBAZEPINE ACETATE Sunovion Pharmaceuticals Inc. NDA Current 63402-208 Aptiom ESLICARBAZEPINE ACETATE Sunovion Pharmaceuticals NDA Current 63402-208 Aptiom ESLICARBAZEPINE ACETATE Sunovion Pharmaceuticals Inc. NDA Current 63402-248 Aptiom ESLICARBAZEPINE ACETATE Sunovion Pharmaceuticals Inc. NDA Current 63402-248 Aptiom ESLICARBAZEPINE ACETATE Sunovion Pharmaceuticals NDA Current 63402-248 Aptiom ESLICARBAZEPINE ACETATE Sunovion Pharmaceuticals Inc. NDA Current