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 44 .
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 4 of 5 · 176 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 2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 3a93d1ddd44b…
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