Home Applications 211199 Application 211199
Type ANDA
Sponsor ALKEM LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE TABLET;ORAL 200MG No No 002 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE TABLET;ORAL 400MG No No 003 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE TABLET;ORAL 600MG No No 004 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE TABLET;ORAL 800MG No No
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 A211199-001 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 A211199-002 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 A211199-003 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 A211199-004 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 2 · 80 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 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211199-001 PC 2025-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211199-002 PC 2025-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211199-003 PC 2025-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211199-004 PC 2025-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211199-001 PC 2025-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211199-002 PC 2025-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211199-003 PC 2025-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211199-004 PC 2025-11-02 6a471c1ec25d…
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.