← FDA DRUG APPROVALS

FDA NDA · NDA021590

FAZACLO ODT

Sponsor: JAZZ

APPLICATION
NDA021590
TYPE
NDA
ORIGINAL APPROVAL
2004-02-10
LATEST ACTION
2020-04-14
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

FAZACLO ODT · ReferenceDiscontinued
CLOZAPINE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
FAZACLO ODT · ReferenceDiscontinued
CLOZAPINE 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
FAZACLO ODT · ReferenceDiscontinued
CLOZAPINE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
FAZACLO ODT · ReferenceDiscontinued
CLOZAPINE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
FAZACLO ODT · ReferenceDiscontinued
CLOZAPINE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
FAZACLO ODT · ReferenceDiscontinued
CLOZAPINE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2020-04-14Labeling · Supplement 32 · 901 required — Label ↗AP
2019-01-16REMS · Supplement 31 — Letter ↗AP
2017-02-23Labeling · Supplement 30 · 901 required — Label ↗AP
2016-04-25Manufacturing (CMC) · Supplement 29 · standardAP
2015-09-30Labeling · Supplement 28 · standard — Letter ↗AP
2015-09-15REMS · Supplement 14 — Label ↗AP
2015-09-15Labeling · Supplement 27 · standard — Label ↗AP
2013-07-19Labeling · Supplement 21 · standard — Letter ↗AP
2012-11-07Manufacturing (CMC) · Supplement 25 · standardAP
2012-01-09Labeling · Supplement 24 · standard — Label ↗AP
2010-12-01Labeling · Supplement 18 · 901 required — Label ↗AP
2010-09-08Labeling · Supplement 17 · standard — Label ↗AP
2010-07-09Labeling · Supplement 15 · standard — Label ↗AP
2010-07-09Manufacturing (CMC) · Supplement 16 · standard — Label ↗AP
2008-08-14Labeling · Supplement 13 · standard — Letter ↗AP
2008-07-15Labeling · Supplement 11 · standard — Letter ↗AP
2007-05-30Manufacturing (CMC) · Supplement 10 — Label ↗AP
2006-02-16Labeling · Supplement 9 · standard — Letter ↗AP
2005-08-12Labeling · Supplement 3 · standard — Letter ↗AP
2005-08-12Labeling · Supplement 8 · standard — Label ↗AP
2005-06-08Labeling · Supplement 7 · standard — Label ↗AP
2004-09-03Labeling · Supplement 2 · standard — Letter ↗AP
2004-06-17Labeling · Supplement 1 · standard — Letter ↗AP
2004-02-10Type 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 →