← FDA DRUG APPROVALS

FDA NDA · NDA214679

EPRONTIA

topiramate

Sponsor: AZURITY

APPLICATION
NDA214679
TYPE
NDA
ORIGINAL APPROVAL
2021-11-05
LATEST ACTION
2026-03-06
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

EPRONTIA · ReferencePrescription
TOPIRAMATE 25MG/ML · SOLUTION · ORAL

Approval history

2026-03-06Labeling · Supplement 12 · standard — Label ↗AP
2025-03-12Labeling · Supplement 9 · standard — Letter ↗AP
2024-05-17Labeling · Supplement 7 · standard — Letter ↗AP
2022-10-26Labeling · Supplement 2 · standard — Label ↗AP
2021-11-05Type 3 - New Dosage Form · Original · standard — Letter ↗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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