← FDA DRUG APPROVALS

FDA NDA · NDA020954

BUSULFEX

Sponsor: OTSUKA PHARM

APPLICATION
NDA020954
TYPE
NDA
ORIGINAL APPROVAL
1999-02-04
LATEST ACTION
2020-03-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BUSULFEX · ReferencePrescription
BUSULFAN 6MG/ML · INJECTABLE · INJECTION

Approval history

2020-03-11Labeling · Supplement 20 · standard — Letter ↗AP
2018-09-28Labeling · Supplement 19 · standard — Letter ↗AP
2018-09-28Labeling · Supplement 18 · standard — Letter ↗AP
2018-01-24Labeling · Supplement 17 · standard — Label ↗AP
2016-05-19Labeling · Supplement 16 · standard — Label ↗AP
2015-10-28Manufacturing (CMC) · Supplement 15 · priorityAP
2015-01-16Labeling · Supplement 14 · standard — Letter ↗AP
2014-09-04Manufacturing (CMC) · Supplement 13 · priorityAP
2011-06-23Labeling · Supplement 10 · unknown — Label ↗AP
2011-06-23Labeling · Supplement 9 · standard — Label ↗AP
2007-04-19Manufacturing (CMC) · Supplement 8 — Label ↗AP
2003-01-13Efficacy · Supplement 4 · priority — Review ↗AP
2002-12-23Labeling · Supplement 1 · standard — Letter ↗AP
2002-11-13Manufacturing (CMC) · Supplement 5 · priority — Label ↗AP
2002-04-24Labeling · Supplement 3 · standard — Letter ↗AP
1999-12-07Manufacturing (CMC) · Supplement 2 · priorityAP
1999-02-04Type 3 - New Dosage Form · Original · priority — Review ↗AP
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 →