ezogabine Oral Tablet
- Brand(s)
- Potiga
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Glaxosmithkline Llc (2014-05-26)
- Oldest Current Product
- 2012-04-19
- License(s)
- NDA
- RxNORM
- ORAL TABLET\EZOGABINE
- FDAOB
- ORAL\TABLET\EZOGABINE
- SPL Active
- ORAL\TABLET, FILM COATED\EZOGABINE
- SPL Moiety
- ORAL\TABLET, FILM COATED\EZOGABINE
product(s) by strength(s)
ezogabine 200 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001730812 | Potiga | NDA | Glaxosmithkline Llc | 2012-04-19 | EZOGABINE | ORAL | TABLET, FILM COATED | NDA022345 | 0c60979b-489d-4e7b-8893-468ae00c44bb |
ezogabine 300 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001730813 | Potiga | NDA | Glaxosmithkline Llc | 2012-04-19 | EZOGABINE | ORAL | TABLET, FILM COATED | NDA022345 | 0c60979b-489d-4e7b-8893-468ae00c44bb |
ezogabine 400 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001730814 | Potiga | NDA | Glaxosmithkline Llc | 2012-04-19 | EZOGABINE | ORAL | TABLET, FILM COATED | NDA022345 | 0c60979b-489d-4e7b-8893-468ae00c44bb |
ezogabine 50 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001730810 | Potiga | NDA | Glaxosmithkline Llc | 2012-04-19 | EZOGABINE | ORAL | TABLET, FILM COATED | NDA022345 | 0c60979b-489d-4e7b-8893-468ae00c44bb |
application(s)
| # | id | title | applicant | approved | exclusivity | approved drug |
|---|---|---|---|---|---|---|
| 1 | NDA022345 | POTIGA | GLAXOSMITHKLINE | 2011-06-10 | NEW CHEMICAL ENTITY [2016-06-10] | NDA022345_001, NDA022345_002, NDA022345_003, NDA022345_004 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA022345_001 | RX | EZOGABINE (50MG) | ORAL | TABLET | False | 2011-06-10 | POTIGA |
| 2 | NDA022345_002 | RX | EZOGABINE (200MG) | ORAL | TABLET | False | 2011-06-10 | POTIGA |
| 3 | NDA022345_003 | RX | EZOGABINE (300MG) | ORAL | TABLET | False | 2011-06-10 | POTIGA |
| 4 | NDA022345_004 | RX | EZOGABINE (400MG) | ORAL | TABLET | True | 2011-06-10 | POTIGA |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 0c60979b-489d-4e7b-8893-468ae00c44bb (view SPL) | These highlights do not include all the information needed to use POTIGA safely and effectively. See full prescribing information for POTIGA. POTIGA (ezogabine) tablets, for oral use, CVInitial U.S. Approval: 2011 | prescription | Human Prescription | Glaxosmithkline Llc | 2014-05-26 | 10 | 001730810, 001730812, 001730813, 001730814 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII