← FDA DRUG APPROVALS

FDA NDA · NDA213978

TYRVAYA

varenicline

Sponsor: OYSTER POINT PHARMA

APPLICATION
NDA213978
TYPE
NDA
ORIGINAL APPROVAL
2021-10-15
LATEST ACTION
2024-02-02
ROUTE
NASAL
DOSAGE FORM
SPRAY
MARKETING STATUS
Prescription

Products

TYRVAYA · ReferencePrescription
VARENICLINE TARTRATE EQ 0.03MG BASE/SPRAY · SPRAY · NASAL

Approval history

2024-02-02Labeling · Supplement 5 · standard — Letter ↗AP
2021-10-15Type 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →