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FDA NDA · NDA216386

ZAVZPRET

zavegepant

Sponsor: PFIZER

APPLICATION
NDA216386
TYPE
NDA
ORIGINAL APPROVAL
2023-03-09
LATEST ACTION
2025-08-01
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription

Products

ZAVZPRET · ReferencePrescription
ZAVEGEPANT HYDROCHLORIDE EQ 10MG BASE/SPRAY · SPRAY, METERED · NASAL

Approval history

2025-08-01Labeling · Supplement 7 · standard — Label ↗AP
2025-03-21Labeling · Supplement 5 · standard — Label ↗AP
2023-03-09Type 1 - New Molecular Entity · 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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