← FDA DRUG APPROVALS

FDA NDA · NDA014691

ALKERAN

Sponsor: APOTEX

APPLICATION
NDA014691
TYPE
NDA
ORIGINAL APPROVAL
1964-01-17
LATEST ACTION
2011-06-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ALKERAN · ReferenceDiscontinued
MELPHALAN 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2011-06-09Labeling · Supplement 29 · standard — Letter ↗AP
2011-05-02Labeling · Supplement 30 · standard — Letter ↗AP
2005-06-09Labeling · Supplement 28 · standard — Letter ↗AP
2003-05-14Labeling · Supplement 24 · standard — Label ↗AP
2002-01-07Labeling · Supplement 23 · standard — Letter ↗AP
2001-10-09Manufacturing (CMC) · Supplement 22 · priorityAP
2001-10-09Manufacturing (CMC) · Supplement 21 · priorityAP
2001-05-24Manufacturing (CMC) · Supplement 20 · priority — Letter ↗AP
1999-07-14Manufacturing (CMC) · Supplement 19 · priorityAP
1998-07-22Manufacturing (CMC) · Supplement 18 · priorityAP
1994-08-25Labeling · Supplement 16 · standardAP
1990-03-26Manufacturing (CMC) · Supplement 14 · priorityAP
1989-09-26Labeling · Supplement 15AP
1987-04-09Labeling · Supplement 13AP
1986-09-22Labeling · Supplement 12AP
1984-09-19Manufacturing (CMC) · Supplement 11 · priorityAP
1984-07-19Labeling · Supplement 10AP
1982-03-24Manufacturing (CMC) · Supplement 8 · priorityAP
1980-06-16Labeling · Supplement 7AP
1980-06-16Labeling · Supplement 6AP
1964-01-17Type 1 - New Molecular Entity · Original · priorityAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →