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FDA NDA · NDA021462

ALIMTA

pemetrexed disodium

Sponsor: LILLY

APPLICATION
NDA021462
TYPE
NDA
ORIGINAL APPROVAL
2004-02-04
LATEST ACTION
2022-08-31
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ALIMTA · ReferencePrescription
PEMETREXED DISODIUM EQ 500MG BASE/VIAL · POWDER · INTRAVENOUS
ALIMTA · ReferencePrescription
PEMETREXED DISODIUM EQ 100MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2022-08-31Efficacy · Supplement 55 · standard — Letter ↗AP
2019-01-30Efficacy · Supplement 53 · standard — Label ↗AP
2018-06-04Efficacy · Supplement 51 · standard — Label ↗AP
2018-04-17Labeling · Supplement 52 · standard — Letter ↗AP
2017-10-11Labeling · Supplement 50 · standard — Label ↗AP
2016-01-08Manufacturing (CMC) · Supplement 49 · priorityAP
2014-08-11Manufacturing (CMC) · Supplement 47 · priorityAP
2013-09-12Labeling · Supplement 45 · standard — Letter ↗AP
2013-03-13Manufacturing (CMC) · Supplement 41 · priorityAP
2013-01-18Manufacturing (CMC) · Supplement 42 · priority — Label ↗AP
2012-11-09Labeling · Supplement 43 · standard — Label ↗AP
2012-10-17Efficacy · Supplement 39 · standard — Letter ↗AP
2012-06-04Labeling · Supplement 40 · standard — Label ↗AP
2011-11-18Efficacy · Supplement 29 · standard — Label ↗AP
2011-11-18Labeling · Supplement 32 · standard — Letter ↗AP
2011-11-18Labeling · Supplement 30 · unknown — Letter ↗AP
2011-03-17Efficacy · Supplement 33 · priority — Letter ↗AP
2009-07-02Efficacy · Supplement 21 · unknown — Label ↗AP
2009-07-02Labeling · Supplement 18 · standard — Label ↗AP
2009-07-02Labeling · Supplement 22 · standard — Letter ↗AP
2008-09-26Efficacy · Supplement 15 · standard — Review ↗AP
2007-09-07Manufacturing (CMC) · Supplement 12 — Label ↗AP
2007-02-02Manufacturing (CMC) · Supplement 6 — Letter ↗AP
2006-07-28Labeling · Supplement 4 · standard — Label ↗AP
2004-08-19Labeling · Supplement 1 · standard — Letter ↗AP
2004-02-04Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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