← FDA DRUG APPROVALS

FDA NDA · NDA022416

APTIOM

eslicarbazepine acetate

Sponsor: SUMITOMO PHARMA AM

APPLICATION
NDA022416
TYPE
NDA
ORIGINAL APPROVAL
2013-11-08
LATEST ACTION
2024-06-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

APTIOM · ReferencePrescription
ESLICARBAZEPINE ACETATE 600MG · TABLET · ORAL
APTIOM · ReferencePrescription
ESLICARBAZEPINE ACETATE 200MG · TABLET · ORAL
APTIOM · ReferencePrescription
ESLICARBAZEPINE ACETATE 800MG · TABLET · ORAL
APTIOM · ReferencePrescription
ESLICARBAZEPINE ACETATE 400MG · TABLET · ORAL

Approval history

2024-06-20Manufacturing (CMC) · Supplement 21 — Label ↗AP
2019-03-15Efficacy · Supplement 11 · standard — Letter ↗AP
2017-09-13Efficacy · Supplement 9 · priority — Label ↗AP
2017-03-07Labeling · Supplement 6 · standard — Letter ↗AP
2016-01-06Manufacturing (CMC) · Supplement 5 · standardAP
2015-09-10Manufacturing (CMC) · Supplement 4 · standardAP
2015-08-27Efficacy · Supplement 1 · standard — Label ↗AP
2015-06-11Manufacturing (CMC) · Supplement 2 · standardAP
2013-11-08Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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