APPLICATION
ANDA206018
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-19
LATEST ACTION
2023-05-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MELPHALAN HYDROCHLORIDEPrescription
MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2023-05-15Labeling · Supplement 2 · standardAP
2016-12-19UNKNOWN · 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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