FDA ANDA · ANDA202873
CLOZAPINE
Sponsor: ACCORD HLTHCARE
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APPLICATION
ANDA202873
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-25
LATEST ACTION
2026-10-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLOZAPINEPrescription
CLOZAPINE 25MG · TABLET · ORAL
CLOZAPINEPrescription
CLOZAPINE 100MG · TABLET · ORAL
Approval history
2026-10-02Labeling · Supplement 18 · standardAP
2026-10-02Labeling · Supplement 17 · standardAP
2026-10-02Labeling · Supplement 21 · standardAP
2025-06-13REMS · Supplement 19AP
2024-03-06Labeling · Supplement 7 · standardAP
2024-03-06Labeling · Supplement 3 · standardAP
2024-03-06Labeling · Supplement 14 · standardAP
2024-03-06Labeling · Supplement 15 · standardAP
2024-03-06Labeling · Supplement 13 · standardAP
2021-11-10REMS · Supplement 11AP
2021-07-29REMS · Supplement 10AP
2021-02-18REMS · Supplement 8AP
2019-01-16REMS · Supplement 5AP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →