APPLICATION
ANDA203807
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-17
LATEST ACTION
2025-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CLOZAPINEDiscontinued
CLOZAPINE 200MG · TABLET · ORAL
CLOZAPINEDiscontinued
CLOZAPINE 100MG · TABLET · ORAL
CLOZAPINEDiscontinued
CLOZAPINE 50MG · TABLET · ORAL
CLOZAPINEDiscontinued
CLOZAPINE 25MG · TABLET · ORAL
Approval history
2025-06-13REMS · Supplement 17AP
2021-11-10REMS · Supplement 14AP
2021-07-29REMS · Supplement 13AP
2021-02-18REMS · Supplement 10AP
2019-01-16REMS · Supplement 6AP
2017-05-10Labeling · Supplement 5 · standardAP
2017-05-10Labeling · Supplement 3 · standardAP
2017-05-10Labeling · Supplement 1 · standardAP
2017-05-10Labeling · Supplement 2 · 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.
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