Home Applications 213109 Application 213109
Type ANDA
Sponsor UNICHEM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG No No 002 LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG No No 003 LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG No No 004 LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG 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 A213109-001 LACOSAMIDE LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 A213109-002 LACOSAMIDE LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 A213109-003 LACOSAMIDE LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 A213109-004 LACOSAMIDE LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04
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 · 44 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 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lacosamide LACOSAMIDE Unichem Pharmaceuticals (USA), Inc. 7ed5cebe-470e-48a4-86ec-2ce79cc32688 2024-09-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 213109 application number: ANDA213109