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FDA ANDA · ANDA078729

ARSENIC TRIOXIDE

Sponsor: TEVA PHARMS

APPLICATION
ANDA078729
TYPE
ANDA
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
None (Tentative Approval)

Products

ARSENIC TRIOXIDENone (Tentative Approval)
ARSENIC TRIOXIDE 10ML · INJECTABLE · INJECTION

Approval history

2008-10-03OriginalTA
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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