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FDA ANDA · ANDA065515

DOXORUBICIN HYDROCHLORIDE

Sponsor: ALMAJECT

APPLICATION
ANDA065515
TYPE
ANDA
ORIGINAL APPROVAL
2012-11-08
LATEST ACTION
2025-06-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DOXORUBICIN HYDROCHLORIDEDiscontinued
DOXORUBICIN HYDROCHLORIDE 2MG/ML · INJECTABLE · INJECTION

Approval history

2025-06-25Labeling · Supplement 3 · standardAP
2025-06-25Labeling · Supplement 1 · standardAP
2025-06-25Labeling · Supplement 4 · standardAP
2012-11-08OriginalAP
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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