← FDA DRUG APPROVALS

FDA NDA · NDA022065

IXEMPRA

ixabepilone

Sponsor: R-PHARM US LLC

APPLICATION
NDA022065
TYPE
NDA
ORIGINAL APPROVAL
2007-10-16
LATEST ACTION
2023-01-11
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

IXEMPRA KIT · ReferencePrescription
IXABEPILONE 45MG/VIAL · INJECTABLE · INTRAVENOUS
IXEMPRA KIT · ReferencePrescription
IXABEPILONE 15MG/VIAL · INJECTABLE · INTRAVENOUS

Approval history

2023-01-11Labeling · Supplement 13 · standard — Letter ↗AP
2022-01-21Labeling · Supplement 11 · standard — Letter ↗AP
2016-12-22Manufacturing (CMC) · Supplement 10 · standardAP
2016-07-26Labeling · Supplement 9 · standardAP
2015-01-20Manufacturing (CMC) · Supplement 8 · priorityAP
2011-10-18Efficacy · Supplement 6 · priority — Label ↗AP
2010-05-12Labeling · Supplement 4 · standard — Label ↗AP
2010-05-12Labeling · Supplement 5 · unknown — Label ↗AP
2009-10-02Efficacy · Supplement 2 · standard — Label ↗AP
2009-10-02Labeling · Supplement 3 · standard — Letter ↗AP
2009-03-13Manufacturing (CMC) · Supplement 1 — Label ↗AP
2007-10-16Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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