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FDA NDA · NDA020207

ALKERAN

Sponsor: APOTEX

APPLICATION
NDA020207
TYPE
NDA
ORIGINAL APPROVAL
1992-11-18
LATEST ACTION
2011-06-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ALKERAN · ReferenceDiscontinued
MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2011-06-09Labeling · Supplement 16 · standard — Letter ↗AP
2011-05-02Labeling · Supplement 17 · standard — Letter ↗AP
2005-06-14Labeling · Supplement 12 · standard — Letter ↗AP
2003-04-29Labeling · Supplement 7 · standard — Label ↗AP
2002-01-07Labeling · Supplement 5 · standard — Letter ↗AP
2001-10-09Manufacturing (CMC) · Supplement 4 · priorityAP
2001-10-09Manufacturing (CMC) · Supplement 3 · priorityAP
2000-03-03Manufacturing (CMC) · Supplement 2 · priorityAP
1994-01-05Labeling · Supplement 1 · standardAP
1992-11-18Type 3 - New Dosage Form · Original · priorityAP
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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