← FDA DRUG APPROVALS

FDA NDA · NDA022363

LIVALO

pitavastatin calcium

Sponsor: KOWA CO

APPLICATION
NDA022363
TYPE
NDA
ORIGINAL APPROVAL
2009-08-03
LATEST ACTION
2024-03-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LIVALO · ReferencePrescription
PITAVASTATIN CALCIUM EQ 2MG BASE · TABLET · ORAL
LIVALO · ReferencePrescription
PITAVASTATIN CALCIUM EQ 4MG BASE · TABLET · ORAL
LIVALO · ReferencePrescription
PITAVASTATIN CALCIUM EQ 1MG BASE · TABLET · ORAL

Approval history

2024-03-14Labeling · Supplement 22 · standard — Label ↗AP
2022-11-09Labeling · Supplement 20 · standard — Label ↗AP
2020-09-25Labeling · Supplement 18 · 901 required — Letter ↗AP
2019-10-18Labeling · Supplement 17 · standard — Label ↗AP
2019-05-16Efficacy · Supplement 15 · priority — Letter ↗AP
2016-11-18Efficacy · Supplement 11 · standard — Letter ↗AP
2015-04-21Manufacturing (CMC) · Supplement 13 · standardAP
2013-10-16Labeling · Supplement 12 · standard — Label ↗AP
2012-10-31Labeling · Supplement 10 · 901 required — Label ↗AP
2012-02-28Labeling · Supplement 9 · unknown — Letter ↗AP
2012-02-28Labeling · Supplement 8 · unknown — Label ↗AP
2011-08-03Labeling · Supplement 6 · unknown — Label ↗AP
2011-06-16Labeling · Supplement 5 · unknown — Label ↗AP
2010-06-01Labeling · Supplement 2 · standard — Letter ↗AP
2009-08-03Type 1 - New Molecular Entity · Original · standard — Label ↗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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