APPLICATION
ANDA212923
TYPE
ANDA
ORIGINAL APPROVAL
2024-12-12
LATEST ACTION
2025-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
CLOZAPINEPrescription
CLOZAPINE 150MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLOZAPINEPrescription
CLOZAPINE 25MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLOZAPINEPrescription
CLOZAPINE 200MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLOZAPINEPrescription
CLOZAPINE 100MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLOZAPINEPrescription
CLOZAPINE 12.5MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2025-06-13REMS · Supplement 2AP
2025-06-13Labeling · Supplement 3 · standardAP
2025-05-09Labeling · Supplement 1 · standardAP
2024-12-12UNKNOWN · Original · standardAP
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.