APPLICATION
ANDA075417
TYPE
ANDA
ORIGINAL APPROVAL
1999-05-27
LATEST ACTION
2025-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
CLOZAPINEPrescription
CLOZAPINE 200MG · TABLET · ORAL
CLOZAPINEDiscontinued
CLOZAPINE 12.5MG · TABLET · ORAL
CLOZAPINEPrescription
CLOZAPINE 25MG · TABLET · ORAL
CLOZAPINEPrescription
CLOZAPINE 50MG · TABLET · ORAL
CLOZAPINEPrescription
CLOZAPINE 100MG · TABLET · ORAL
Approval history
2025-06-13REMS · Supplement 63AP
2024-07-08Labeling · Supplement 59 · standardAP
2024-07-08Labeling · Supplement 57 · standardAP
2024-07-08Labeling · Supplement 47 · standardAP
2024-07-08Labeling · Supplement 44 · standardAP
2021-11-10REMS · Supplement 51AP
2021-07-29REMS · Supplement 49AP
2021-02-18REMS · Supplement 46AP
2019-01-16REMS · Supplement 41AP
2017-04-25Labeling · Supplement 39 · standardAP
2017-04-25Labeling · Supplement 38 · standardAP
2017-04-25Labeling · Supplement 40 · standardAP
2015-09-15REMS · Supplement 37AP
2015-09-14Labeling · Supplement 36 · standardAP
2014-12-13Labeling · Supplement 35 · standardAP
2014-12-13Labeling · Supplement 34 · standardAP
2013-08-26Labeling · Supplement 33 · standardAP
2013-05-20Labeling · Supplement 31AP
2011-04-11Labeling · Supplement 30AP
2010-04-30Labeling · Supplement 28AP
2009-04-08Labeling · Supplement 22AP
2008-11-19Labeling · Supplement 18AP
2006-10-31Labeling · Supplement 11AP
2006-10-13Labeling · Supplement 10AP
2005-04-08Labeling · Supplement 9AP
2003-03-31Labeling · Supplement 6AP
2003-03-17Labeling · Supplement 4AP
2001-03-12Labeling · Supplement 1AP
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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