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FDA NDA · NDA022328

INTERMEZZO

Sponsor: PURDUE PHARMA

APPLICATION
NDA022328
TYPE
NDA
ORIGINAL APPROVAL
2011-11-23
LATEST ACTION
2019-08-18
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

INTERMEZZO · ReferenceDiscontinued
ZOLPIDEM TARTRATE 1.75MG · TABLET · SUBLINGUAL
INTERMEZZO · ReferenceDiscontinued
ZOLPIDEM TARTRATE 3.5MG · TABLET · SUBLINGUAL

Approval history

2019-08-18Labeling · Supplement 8 · 901 required — Letter ↗AP
2019-02-06Labeling · Supplement 7 · 901 required — Label ↗AP
2015-11-13Manufacturing (CMC) · Supplement 3 · standardAP
2015-09-11Labeling · Supplement 4 · standard — Label ↗AP
2013-06-14Manufacturing (CMC) · Supplement 2 · standardAP
2013-02-06Manufacturing (CMC) · Supplement 1 · standard — Label ↗AP
2011-11-23Type 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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