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 3 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 2019-12-13 00:20 UTC 2019-12 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022345-001 POTIGA 50MG TABLET / ORAL RLD 2011-06-10 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022345-002 POTIGA 200MG TABLET / ORAL RLD 2011-06-10 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022345-003 POTIGA 300MG TABLET / ORAL RLD 2011-06-10 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022345-004 POTIGA 400MG TABLET / ORAL RLD 2011-06-10 ea99ee380514…
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