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FDA ANDA · ANDA090270

MELPHALAN HYDROCHLORIDE

Sponsor: MYLAN INSTITUTIONAL

APPLICATION
ANDA090270
TYPE
ANDA
ORIGINAL APPROVAL
2009-06-09
LATEST ACTION
2015-08-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MELPHALAN HYDROCHLORIDEPrescription
MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2015-08-27Labeling · Supplement 7AP
2011-07-14Labeling · Supplement 5AP
2009-06-09OriginalLetterAP
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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