APPLICATION
ANDA208759
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-12
LATEST ACTION
2020-12-01
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DAUNORUBICIN HYDROCHLORIDEPrescription
DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2020-12-01Manufacturing (CMC) · Supplement 2AP
2019-10-09Manufacturing (CMC) · Supplement 1 · unknownAP
2019-04-12UNKNOWN · 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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