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FDA NDA · NDA022217

VALTURNA

Sponsor: NOVARTIS

APPLICATION
NDA022217
TYPE
NDA
ORIGINAL APPROVAL
2009-09-16
LATEST ACTION
2012-04-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

VALTURNADiscontinued
ALISKIREN HEMIFUMARATE EQ 150MG BASE, VALSARTAN 160MG · TABLET · ORAL
VALTURNADiscontinued
ALISKIREN HEMIFUMARATE EQ 300MG BASE, VALSARTAN 320MG · TABLET · ORAL

Approval history

2012-04-25Labeling · Supplement 20 · standard — Label ↗AP
2012-02-02Labeling · Supplement 17 · standard — Label ↗AP
2012-01-26Labeling · Supplement 16 · standard — Label ↗AP
2011-10-13Labeling · Supplement 14 · standard — Letter ↗AP
2011-05-04Labeling · Supplement 13 · standard — Letter ↗AP
2011-02-10Labeling · Supplement 7 · standard — Letter ↗AP
2010-08-04Labeling · Supplement 5 · standard — Label ↗AP
2009-09-16Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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.

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