← FDA DRUG APPROVALS

FDA ANDA · ANDA090308

CLOZAPINE

Sponsor: BARR LABS INC

APPLICATION
ANDA090308
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-25
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 100MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLOZAPINEPrescription
CLOZAPINE 200MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLOZAPINEPrescription
CLOZAPINE 12.5MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLOZAPINEPrescription
CLOZAPINE 25MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2025-06-13Labeling · Supplement 15 · standardAP
2025-06-13REMS · Supplement 14AP
2025-01-22Labeling · Supplement 13 · standardAP
2023-04-26Labeling · Supplement 12 · standardAP
2021-11-10REMS · Supplement 11AP
2021-07-29REMS · Supplement 9AP
2021-04-16Labeling · Supplement 6 · standardAP
2021-04-09Labeling · Supplement 1 · standardAP
2021-02-18REMS · Supplement 8AP
2019-01-16REMS · Supplement 3AP
2018-04-09Original — Letter ↗AP
2015-11-25Original — Other ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →