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FDA NDA · NDA217110

IVRA

melphalan hcl

Sponsor: APOTEX

APPLICATION
NDA217110
TYPE
NDA
ORIGINAL APPROVAL
2023-08-18
LATEST ACTION
2024-07-22
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

IVRA · ReferencePrescription
MELPHALAN HYDROCHLORIDE EQ 90MG BASE/ML (EQ 90MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-07-22Labeling · Supplement 2 · standard — Letter ↗AP
2023-08-18Type 3 - New Dosage Form · Original · standard — Letter ↗AP
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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