APPLICATION
ANDA203622
TYPE
ANDA
ORIGINAL APPROVAL
2014-06-27
LATEST ACTION
2024-08-28
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DOXORUBICIN HYDROCHLORIDEPrescription
DOXORUBICIN HYDROCHLORIDE 200MG/100ML · INJECTABLE · INJECTION
DOXORUBICIN HYDROCHLORIDEPrescription
DOXORUBICIN HYDROCHLORIDE 2MG/ML · INJECTABLE · INJECTION
Approval history
2024-08-28Labeling · Supplement 9 · standardAP
2024-08-28Labeling · Supplement 5 · standardAP
2024-08-28Labeling · Supplement 4 · standardAP
2014-06-27UNKNOWN · OriginalAP
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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