APPLICATION
ANDA075713
TYPE
ANDA
ORIGINAL APPROVAL
2002-11-15
LATEST ACTION
2025-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CLOZAPINEDiscontinued
CLOZAPINE 200MG · TABLET · ORAL
CLOZAPINEDiscontinued
CLOZAPINE 100MG · TABLET · ORAL
CLOZAPINEDiscontinued
CLOZAPINE 50MG · TABLET · ORAL
CLOZAPINEDiscontinued
CLOZAPINE 25MG · TABLET · ORAL
Approval history
2025-06-13REMS · Supplement 59AP
2024-02-02Labeling · Supplement 57 · standardAP
2024-02-02Labeling · Supplement 49 · standardAP
2024-02-02Labeling · Supplement 51 · standardAP
2024-02-02Labeling · Supplement 56 · standardAP
2021-11-10REMS · Supplement 55AP
2021-07-29REMS · Supplement 54AP
2021-02-18REMS · Supplement 50AP
2019-01-16REMS · Supplement 45AP
2017-11-07Labeling · Supplement 15AP
2017-06-29Labeling · Supplement 38 · standardAP
2017-06-29Labeling · Supplement 39 · standardAP
2017-06-29Labeling · Supplement 41 · standardAP
2015-09-15REMS · Supplement 36AP
2014-06-26Labeling · Supplement 35 · standardAP
2011-12-27Labeling · Supplement 29AP
2011-07-11Labeling · Supplement 28AP
2011-04-05Labeling · Supplement 27AP
2010-02-25Labeling · Supplement 25AP
2009-04-17Labeling · Supplement 22AP
2008-08-19Labeling · Supplement 18AP
2006-10-13Labeling · Supplement 12AP
2006-10-13Labeling · Supplement 11AP
2006-06-30Labeling · Supplement 9AP
2006-03-13Labeling · Supplement 7AP
2005-08-19Labeling · Supplement 6AP
2005-08-19Manufacturing (CMC) · Supplement 5AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.