FDA ANDA · ANDA075417
CLOZAPINE
Sponsor: MYLAN
What this page does not claim
A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.
APPLICATION
ANDA075417
TYPE
ANDA
ORIGINAL APPROVAL
1999-05-27
LATEST ACTION
2026-10-02
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
2026-10-02Labeling · Supplement 61 · standardAP
2026-10-02Labeling · Supplement 64 · standardAP
2026-10-02Labeling · Supplement 62 · standardAP
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. Browse every approval SPEQ tracks →