APPLICATION
ANDA074949
TYPE
ANDA
ORIGINAL APPROVAL
1997-11-26
LATEST ACTION
2026-01-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLOZAPINEPrescription
CLOZAPINE 25MG · TABLET · ORAL
CLOZAPINEPrescription
CLOZAPINE 50MG · TABLET · ORAL
CLOZAPINEPrescription
CLOZAPINE 100MG · TABLET · ORAL
CLOZAPINEPrescription
CLOZAPINE 12.5MG · TABLET · ORAL
Approval history
2026-01-25Labeling · Supplement 88 · standardAP
2026-01-25Labeling · Supplement 89 · standardAP
2026-01-25Labeling · Supplement 79 · standardAP
2026-01-25Labeling · Supplement 91 · standardAP
2026-01-25Labeling · Supplement 83 · standardAP
2025-06-13REMS · Supplement 90AP
2021-11-10REMS · Supplement 86AP
2021-07-29REMS · Supplement 84AP
2021-02-18REMS · Supplement 81AP
2019-01-16REMS · Supplement 75AP
2017-04-26Labeling · Supplement 68 · standardAP
2017-04-26Labeling · Supplement 74 · standardAP
2017-04-26Labeling · Supplement 72 · standardAP
2017-04-26Labeling · Supplement 69 · standardAP
2017-04-26Labeling · Supplement 73 · standardAP
2015-09-15REMS · Supplement 67AP
2015-09-14Labeling · Supplement 66 · standardAP
2014-12-08Labeling · Supplement 64 · standardAP
2014-12-08Labeling · Supplement 65 · standardAP
2014-09-26Labeling · Supplement 44AP
2013-08-26Labeling · Supplement 63AP
2011-12-28Labeling · Supplement 61AP
2011-07-27Labeling · Supplement 60AP
2011-04-11Labeling · Supplement 59AP
2010-10-19Labeling · Supplement 58AP
2009-04-08Labeling · Supplement 52AP
2008-09-23Labeling · Supplement 50AP
2008-09-02Labeling · Supplement 49AP
2008-05-28Labeling · Supplement 47AP
2006-10-13Labeling · Supplement 41AP
2006-10-13Labeling · Supplement 40AP
2005-04-28Labeling · Supplement 34AP
2005-04-25Labeling · Supplement 31AP
2005-04-25Supplement · Supplement 30AP
2003-07-31Manufacturing (CMC) · Supplement 19AP
2003-07-31Labeling · Supplement 20AP
2002-09-04Manufacturing (CMC) · Supplement 21AP
2002-07-29Manufacturing (CMC) · Supplement 27AP
2001-09-12Manufacturing (CMC) · Supplement 22AP
2000-01-28Manufacturing (CMC) · Supplement 18AP
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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