← FDA DRUG APPROVALS

FDA NDA · NDA050443

BLENOXANE

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA050443
TYPE
NDA
ORIGINAL APPROVAL
1973-07-31
LATEST ACTION
2010-05-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

BLENOXANE · ReferenceDiscontinued
BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
BLENOXANE · ReferenceDiscontinued
BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2010-05-10Labeling · Supplement 36 · standard — Review ↗AP
2004-06-30Labeling · Supplement 27 · standard — Letter ↗AP
2003-03-21Labeling · Supplement 35 · standard — Label ↗AP
2002-03-20Manufacturing (CMC) · Supplement 33AP
2000-07-03Manufacturing (CMC) · Supplement 32AP
2000-07-03Manufacturing (CMC) · Supplement 30AP
2000-04-12Manufacturing (CMC) · Supplement 31AP
1999-10-20Labeling · Supplement 29 · standardAP
1999-08-25Labeling · Supplement 28 · standardAP
1996-09-30Manufacturing (CMC) · Supplement 26 — Review ↗AP
1996-02-20Efficacy · Supplement 25 · standardAP
1995-09-07Manufacturing (CMC) · Supplement 24AP
1994-01-21Manufacturing (CMC) · Supplement 22AP
1994-01-21Manufacturing (CMC) · Supplement 19AP
1994-01-21Manufacturing (CMC) · Supplement 17AP
1994-01-21Manufacturing (CMC) · Supplement 21AP
1993-02-23Labeling · Supplement 23 · standardAP
1991-01-30Manufacturing (CMC) · Supplement 20AP
1983-10-21Manufacturing (CMC) · Supplement 14AP
1983-10-19Manufacturing (CMC) · Supplement 13AP
1983-09-26Manufacturing (CMC) · Supplement 12AP
1983-04-13Labeling · Supplement 11AP
1982-12-13Manufacturing (CMC) · Supplement 10AP
1976-12-21Labeling · Supplement 9AP
1976-04-05Manufacturing (CMC) · Supplement 5AP
1976-03-31Manufacturing (CMC) · Supplement 7AP
1976-03-15Labeling · Supplement 8AP
1975-10-10Manufacturing (CMC) · Supplement 6AP
1975-10-08Labeling · Supplement 4AP
1975-03-05Manufacturing (CMC) · Supplement 3AP
1974-08-09Labeling · Supplement 2AP
1973-07-31Type 1 - New Molecular Entity · Original · unknownAP
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 →