← FDA DRUG APPROVALS

FDA NDA · NDA022345

POTIGA

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA022345
TYPE
NDA
ORIGINAL APPROVAL
2011-06-10
LATEST ACTION
2016-05-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

POTIGA · ReferenceDiscontinued
EZOGABINE 400MG · TABLET · ORAL
POTIGA · ReferenceDiscontinued
EZOGABINE 200MG · TABLET · ORAL
POTIGA · ReferenceDiscontinued
EZOGABINE 300MG · TABLET · ORAL
POTIGA · ReferenceDiscontinued
EZOGABINE 50MG · TABLET · ORAL

Approval history

2016-05-20Labeling · Supplement 11 · standard — Label ↗AP
2015-11-25REMS · Supplement 9 — Letter ↗AP
2015-05-26Labeling · Supplement 10 · standard — Label ↗AP
2013-09-06Labeling · Supplement 6 · standard — Letter ↗AP
2013-06-06Labeling · Supplement 7 · standard — Letter ↗AP
2012-11-21Manufacturing (CMC) · Supplement 4 · standardAP
2012-03-19Labeling · Supplement 1 · unknown — Label ↗AP
2011-06-10Type 1 - New Molecular Entity · Original · standard — Medication Guide ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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