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FDA ANDA · ANDA212299

DOXORUBICIN HYDROCHLORIDE

Sponsor: ZYDUS LIFESCIENCES

APPLICATION
ANDA212299
TYPE
ANDA
ORIGINAL APPROVAL
2020-09-10
LATEST ACTION
2025-01-03
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE, LIPOSOMAL
MARKETING STATUS
Prescription

Products

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)Prescription
DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) · INJECTABLE, LIPOSOMAL · INJECTION
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)Prescription
DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) · INJECTABLE, LIPOSOMAL · INJECTION

Approval history

2025-01-03Labeling · Supplement 7 · standardAP
2020-09-10UNKNOWN · Original · standardAP
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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