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FDA NDA · NDA205394

RIZAFILM

rizatriptan benzoate

Sponsor: GENSCO

APPLICATION
NDA205394
TYPE
NDA
ORIGINAL APPROVAL
2023-04-14
LATEST ACTION
2026-02-26
ROUTE
ORAL
DOSAGE FORM
FILM
MARKETING STATUS
Discontinued

Products

RIZAFILM · ReferenceDiscontinued
RIZATRIPTAN BENZOATE EQ 5MG BASE · FILM · ORAL
RIZAFILM · ReferenceDiscontinued
RIZATRIPTAN BENZOATE EQ 10MG BASE · FILM · ORAL

Approval history

2026-02-26Efficacy · Supplement 5 · standard — Label ↗AP
2026-01-29Labeling · Supplement 7 · standard — Label ↗AP
2023-12-11Labeling · Supplement 2 · standard — Letter ↗AP
2023-04-14Type 3 - New Dosage Form · Original · standard — Label ↗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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