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FDA ANDA · ANDA206228

ARSENIC TRIOXIDE

Sponsor: ZYDUS PHARMS

APPLICATION
ANDA206228
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-13
LATEST ACTION
2026-06-02
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ARSENIC TRIOXIDEPrescription
ARSENIC TRIOXIDE 1MG/ML · INJECTABLE · INJECTION
ARSENIC TRIOXIDEPrescription
ARSENIC TRIOXIDE 2MG/ML · INJECTABLE · INJECTION

Approval history

2026-06-02Labeling · Supplement 13 · standardAP
2024-07-08Labeling · Supplement 4 · standardAP
2018-11-13UNKNOWN · Original · standardAP
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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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