← FDA DRUG APPROVALS

FDA NDA · NDA019758

CLOZARIL

clozapine

Sponsor: HERITAGE LIFE

APPLICATION
NDA019758
TYPE
NDA
ORIGINAL APPROVAL
1989-09-26
LATEST ACTION
2025-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

CLOZARIL · ReferenceDiscontinued
CLOZAPINE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CLOZARIL · ReferencePrescription
CLOZAPINE 100MG · TABLET · ORAL
CLOZARIL · ReferenceDiscontinued
CLOZAPINE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CLOZARIL · ReferencePrescription
CLOZAPINE 25MG · TABLET · ORAL

Approval history

2025-06-13REMS · Supplement 107LabelAP
2025-01-22Labeling · Supplement 106 · standardLabelAP
2024-09-12Labeling · Supplement 104 · standardLabelAP
2023-05-19Labeling · Supplement 103 · standardLabelAP
2022-12-19Labeling · Supplement 101 · standardLetterAP
2021-11-10REMS · Supplement 99LetterAP
2021-07-29REMS · Supplement 98LetterAP
2021-02-18REMS · Supplement 96LetterAP
2021-02-11Labeling · Supplement 88 · standardLetterAP
2020-04-14Labeling · Supplement 95 · 901 requiredLabelAP
2019-01-16REMS · Supplement 90LetterAP
2017-02-23Labeling · Supplement 84 · 901 requiredLabelAP
2017-01-26Labeling · Supplement 81 · standardLabelAP
2016-12-20Labeling · Supplement 80 · standardLetterAP
2016-05-06Manufacturing (CMC) · Supplement 79 · priorityAP
2015-11-10Manufacturing (CMC) · Supplement 76 · priorityAP
2015-10-08Labeling · Supplement 78 · standardLetterAP
2015-09-18Labeling · Supplement 74 · standardLetterAP
2015-09-15REMS · Supplement 61ReviewAP
2015-09-15Labeling · Supplement 77 · standardLabelAP
2014-12-19Labeling · Supplement 73 · standardLabelAP
2014-09-30Manufacturing (CMC) · Supplement 64 · priorityAP
2014-09-29Labeling · Supplement 72 · standardLetterAP
2013-07-19Labeling · Supplement 69 · standardLetterAP
2013-07-19Labeling · Supplement 71 · standardLabelAP
2013-03-22Labeling · Supplement 67 · standardLetterAP
2013-03-22Labeling · Supplement 68 · standardLabelAP
2013-03-22Labeling · Supplement 70 · standardLetterAP
2011-10-19Labeling · Supplement 63 · unknownLabelAP
2010-12-01Labeling · Supplement 65 · 901 requiredLetterAP
2010-01-14Labeling · Supplement 62 · standardLabelAP
2008-11-06Labeling · Supplement 53 · standardLetterAP
2008-08-14Labeling · Supplement 59 · standardLetterAP
2008-06-26Labeling · Supplement 58 · standardLetterAP
2005-12-05Labeling · Supplement 57 · standardLetterAP
2005-06-29Labeling · Supplement 56 · standardLabelAP
2005-05-12Labeling · Supplement 54 · standardLabelAP
2003-12-23Labeling · Supplement 51 · standardLetterAP
2002-12-18Efficacy · Supplement 47 · priorityLetterAP
2002-07-05Labeling · Supplement 48 · standardLetterAP
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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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