APPLICATION
ANDA201824
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-15
LATEST ACTION
2025-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription, None (Tentative Approval)
Products
CLOZAPINEPrescription
CLOZAPINE 200MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLOZAPINEPrescription
CLOZAPINE 100MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLOZAPINENone (Tentative Approval)
CLOZAPINE 12.5MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLOZAPINEPrescription
CLOZAPINE 150MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLOZAPINEPrescription
CLOZAPINE 25MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2025-06-13Labeling · Supplement 28 · standardAP
2025-06-13REMS · Supplement 27AP
2025-01-22Labeling · Supplement 26 · standardAP
2023-04-26Labeling · Supplement 22 · standardAP
2021-11-10REMS · Supplement 16AP
2021-07-29REMS · Supplement 15AP
2021-02-18REMS · Supplement 13AP
2020-07-26Labeling · Supplement 11 · standardAP
2019-01-16REMS · Supplement 9AP
2017-11-17Labeling · Supplement 7 · standardAP
2016-01-22Labeling · Supplement 4 · standardAP
2016-01-22Labeling · Supplement 5 · standardAP
2015-09-15Not Applicable · OriginalTA
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.