← FDA DRUG APPROVALS

FDA NDA · NDA214697

NEFFY

epinephrine

Sponsor: ARS PHARMS OPERATION

APPLICATION
NDA214697
TYPE
NDA
ORIGINAL APPROVAL
2024-08-09
LATEST ACTION
2026-03-26
ROUTE
NASAL
DOSAGE FORM
SPRAY
MARKETING STATUS
Prescription

Products

NEFFY · ReferencePrescription
EPINEPHRINE 2MG/SPRAY · SPRAY · NASAL
NEFFY · ReferencePrescription
EPINEPHRINE 1MG/SPRAY · SPRAY · NASAL

Approval history

2026-03-26Labeling · Supplement 4 · standard — Letter ↗AP
2026-03-26Efficacy · Supplement 2 · standard — Letter ↗AP
2025-10-24Labeling · Supplement 3 · standard — Label ↗AP
2025-03-05Efficacy · Supplement 1 · priority — Label ↗AP
2024-08-09Type 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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