Home Applications 022345 Application 022345
Type NDA
Sponsor GLAXOSMITHKLINE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 POTIGA EZOGABINE TABLET;ORAL 50MG Yes No 002 POTIGA EZOGABINE TABLET;ORAL 200MG Yes No 003 POTIGA EZOGABINE TABLET;ORAL 300MG Yes No 004 POTIGA EZOGABINE TABLET;ORAL 400MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N022345-001 POTIGA EZOGABINE 50MG TABLET / ORAL RLD 2011-06-10 N022345-002 POTIGA EZOGABINE 200MG TABLET / ORAL RLD 2011-06-10 N022345-003 POTIGA EZOGABINE 300MG TABLET / ORAL RLD 2011-06-10 N022345-004 POTIGA EZOGABINE 400MG TABLET / ORAL RLD 2011-06-10
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 · 172 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 2026-09-14 22:38:34 2026-08 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 5bbf6a4d5a75…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0173-0810 POTIGA ezogabine GlaxoSmithKline LLC NDA Current 0173-0812 POTIGA ezogabine GlaxoSmithKline LLC NDA Current 0173-0814 POTIGA ezogabine GlaxoSmithKline LLC NDA Current