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FDA ANDA · ANDA206433

CLOZAPINE

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA206433
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-29
LATEST ACTION
2025-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CLOZAPINEPrescription
CLOZAPINE 25MG · TABLET · ORAL
CLOZAPINEPrescription
CLOZAPINE 200MG · TABLET · ORAL
CLOZAPINEPrescription
CLOZAPINE 50MG · TABLET · ORAL
CLOZAPINEPrescription
CLOZAPINE 100MG · TABLET · ORAL

Approval history

2025-06-13REMS · Supplement 22AP
2023-08-14Labeling · Supplement 8 · standardAP
2023-08-14Labeling · Supplement 10 · standardAP
2023-08-14Labeling · Supplement 19 · standardAP
2023-08-14Labeling · Supplement 17 · standardAP
2021-11-10REMS · Supplement 13AP
2021-07-29REMS · Supplement 12AP
2021-02-18REMS · Supplement 9AP
2019-01-16REMS · Supplement 4AP
2017-04-25Labeling · Supplement 1 · standardAP
2017-04-25Labeling · Supplement 2 · standardAP
2016-11-29UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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