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FDA NDA · NDA206099

ONZETRA XSAIL

Sponsor: AZURITY

APPLICATION
NDA206099
TYPE
NDA
ORIGINAL APPROVAL
2016-01-27
LATEST ACTION
2019-12-20
ROUTE
NASAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ONZETRA XSAIL · ReferencePrescription
SUMATRIPTAN SUCCINATE EQ 11MG BASE · POWDER · NASAL

Approval history

2019-12-20Labeling · Supplement 6 · standard — Label ↗AP
2019-06-18Labeling · Supplement 5 · standard — Letter ↗AP
2016-11-16Manufacturing (CMC) · Supplement 1 · standardAP
2016-01-27Type 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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