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FDA NDA · NDA022196

ZOLPIMIST

Sponsor: AYTU

APPLICATION
NDA022196
TYPE
NDA
ORIGINAL APPROVAL
2008-12-19
LATEST ACTION
2019-08-18
ROUTE
ORAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued

Products

ZOLPIMIST · ReferenceDiscontinued
ZOLPIDEM TARTRATE 5MG/SPRAY · SPRAY, METERED · ORAL

Approval history

2019-08-18Labeling · Supplement 12 · 901 required — Letter ↗AP
2019-02-06Labeling · Supplement 11 · 901 required — Label ↗AP
2011-09-28REMS · Supplement 7 — Letter ↗AP
2010-10-11REMS · Supplement 3 — Letter ↗AP
2008-12-19Type 3 - New Dosage Form · Original · standard — Review ↗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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