← FDA DRUG APPROVALS

FDA NDA · NDA022545

TEKAMLO

Sponsor: NOVARTIS

APPLICATION
NDA022545
TYPE
NDA
ORIGINAL APPROVAL
2010-08-26
LATEST ACTION
2016-11-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TEKAMLODiscontinued
ALISKIREN HEMIFUMARATE EQ 300MG BASE, AMLODIPINE BESYLATE EQ 5MG BASE · TABLET · ORAL
TEKAMLODiscontinued
ALISKIREN HEMIFUMARATE EQ 150MG BASE, AMLODIPINE BESYLATE EQ 5MG BASE · TABLET · ORAL
TEKAMLODiscontinued
ALISKIREN HEMIFUMARATE EQ 300MG BASE, AMLODIPINE BESYLATE EQ 10MG BASE · TABLET · ORAL
TEKAMLODiscontinued
ALISKIREN HEMIFUMARATE EQ 150MG BASE, AMLODIPINE BESYLATE EQ 10MG BASE · TABLET · ORAL

Approval history

2016-11-04Labeling · Supplement 20 · standard — Letter ↗AP
2015-12-22Labeling · Supplement 17 · standard — Letter ↗AP
2015-03-27Labeling · Supplement 16 · standard — Label ↗AP
2014-03-18Labeling · Supplement 15 · standard — Label ↗AP
2013-11-04Labeling · Supplement 14 · standard — Letter ↗AP
2012-09-28Labeling · Supplement 13 · unknown — Letter ↗AP
2012-09-28Labeling · Supplement 11 · unknown — Label ↗AP
2012-04-16Labeling · Supplement 12 · unknown — Letter ↗AP
2012-02-02Labeling · Supplement 10 · unknown — Label ↗AP
2012-01-26Labeling · Supplement 7 · unknown — Letter ↗AP
2011-11-14Labeling · Supplement 8 · unknown — Label ↗AP
2011-10-12Labeling · Supplement 5 · unknown — Label ↗AP
2011-03-30Labeling · Supplement 1 · standard — Label ↗AP
2010-08-26Type 4 - New Combination · Original · standard — Summary 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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