← FDA DRUG APPROVALS

FDA NDA · NDA022399

HORIZANT

gabapentin enacarbil

Sponsor: AZURITY

APPLICATION
NDA022399
TYPE
NDA
ORIGINAL APPROVAL
2011-04-06
LATEST ACTION
2025-04-25
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

HORIZANT · ReferencePrescription
GABAPENTIN ENACARBIL 600MG · TABLET, EXTENDED RELEASE · ORAL
HORIZANT · ReferencePrescription
GABAPENTIN ENACARBIL 300MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-04-25Labeling · Supplement 14 · standard — Label ↗AP
2020-04-17Labeling · Supplement 10 · standard — Letter ↗AP
2020-04-02Labeling · Supplement 11 · 901 required — Letter ↗AP
2013-10-29Manufacturing (CMC) · Supplement 9 · standardAP
2013-05-01Labeling · Supplement 8 · standard — Label ↗AP
2013-03-27Efficacy · Supplement 5 · standard — Review ↗AP
2012-12-26Labeling · Supplement 6 · standard — Letter ↗AP
2012-12-26Labeling · Supplement 7 · standard — Label ↗AP
2012-06-06Efficacy · Supplement 3 · standard — Review ↗AP
2012-04-18Labeling · Supplement 4 · standard — Letter ↗AP
2011-04-06Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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