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FDA NDA · NDA218879

SUBVENITE

lamotrigine

Sponsor: OWP PHARMS

APPLICATION
NDA218879
TYPE
NDA
ORIGINAL APPROVAL
2025-09-16
LATEST ACTION
2026-07-17
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

SUBVENITE · ReferencePrescription
LAMOTRIGINE 10MG/ML · SUSPENSION · ORAL

Approval history

2026-07-17Labeling · Supplement 1 · standard — Label ↗AP
2026-07-17Labeling · Supplement 2 · standard — Label ↗AP
2025-09-16Type 3 - New Dosage Form · 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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