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FDA NDA · NDA216686

FOCINVEZ

fosaprepitant dimeglumine

Sponsor: STERISCIENCE

APPLICATION
NDA216686
TYPE
NDA
ORIGINAL APPROVAL
2023-08-22
LATEST ACTION
2026-03-30
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

FOCINVEZ · ReferencePrescription
FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/50ML (EQ 3MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-03-30Labeling · Supplement 4 · standard — Label ↗AP
2025-05-29Labeling · Supplement 2 · standard — Letter ↗AP
2023-08-22Type 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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