APPLICATION
ANDA209315
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-15
LATEST ACTION
2021-11-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
ARSENIC TRIOXIDEDiscontinued
ARSENIC TRIOXIDE 2MG/ML · INJECTABLE · INJECTION
ARSENIC TRIOXIDEPrescription
ARSENIC TRIOXIDE 1MG/ML · INJECTABLE · INJECTION
Approval history
2021-11-12Labeling · Supplement 5 · standardAP
2020-05-15Labeling · Supplement 2 · standardAP
2018-11-15UNKNOWN · Original · 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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