← FDA DRUG APPROVALS

FDA NDA · NDA022465

VOTRIENT

pazopanib hydrochloride

Sponsor: NOVARTIS

APPLICATION
NDA022465
TYPE
NDA
ORIGINAL APPROVAL
2009-10-19
LATEST ACTION
2024-01-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

VOTRIENT · ReferencePrescription
PAZOPANIB HYDROCHLORIDE EQ 200MG BASE · TABLET · ORAL
VOTRIENT · ReferenceDiscontinued
PAZOPANIB HYDROCHLORIDE EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2024-01-25Labeling · Supplement 36 · standard — Label ↗AP
2021-12-13Manufacturing (CMC) · Supplement 33 — Letter ↗AP
2021-09-22Labeling · Supplement 31 · standard — Letter ↗AP
2021-09-22Labeling · Supplement 32 · standard — Letter ↗AP
2020-08-17Labeling · Supplement 29 · standard — Letter ↗AP
2020-07-17Labeling · Supplement 30 · standard — Letter ↗AP
2020-06-02Labeling · Supplement 28 · standard — Letter ↗AP
2017-05-31Labeling · Supplement 24 · standard — Label ↗AP
2017-05-31Labeling · Supplement 25 · standard — Label ↗AP
2016-08-05Labeling · Supplement 23 · standard — Letter ↗AP
2016-05-20Labeling · Supplement 22 · standard — Label ↗AP
2015-09-22Labeling · Supplement 21 · standard — Label ↗AP
2015-04-01Labeling · Supplement 20 · standard — Letter ↗AP
2014-11-18Efficacy · Supplement 19 · standard — Letter ↗AP
2014-06-03Labeling · Supplement 18 · standard — Label ↗AP
2013-11-27Labeling · Supplement 17 · standard — Label ↗AP
2013-08-14Labeling · Supplement 16 · standard — Label ↗AP
2013-08-14Labeling · Supplement 14 · standard — Label ↗AP
2013-08-14Labeling · Supplement 15 · standard — Label ↗AP
2012-11-15Labeling · Supplement 13 · standard — Label ↗AP
2012-04-26Labeling · Supplement 12 · standard — Label ↗AP
2012-04-26Efficacy · Supplement 10 · standard — Letter ↗AP
2012-03-20Labeling · Supplement 11 · standard — Letter ↗AP
2012-01-12Efficacy · Supplement 7 · standard — Label ↗AP
2011-10-21Labeling · Supplement 5 · unknown — Label ↗AP
2011-10-21Labeling · Supplement 3 · unknown — Letter ↗AP
2011-04-21REMS · Supplement 6 — Letter ↗AP
2010-04-27Labeling · Supplement 2 · unknown — Label ↗AP
2009-10-19Type 1 - New Molecular Entity · Original · unknown — Letter ↗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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