← FDA DRUG APPROVALS

FDA ANDA · ANDA078167

PACLITAXEL

Sponsor: SANDOZ

APPLICATION
ANDA078167
TYPE
ANDA
ORIGINAL APPROVAL
2007-12-26
LATEST ACTION
2015-10-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

PACLITAXELDiscontinued
PACLITAXEL 6MG/ML · INJECTABLE · INJECTION

Approval history

2015-10-14Labeling · Supplement 12 · standardAP
2015-10-14Labeling · Supplement 7 · standardAP
2011-09-13Labeling · Supplement 5AP
2011-08-30Labeling · Supplement 6AP
2007-12-26OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →