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FDA ANDA · ANDA077262

AMLODIPINE BESYLATE

Sponsor: HIKMA

APPLICATION
ANDA077262
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-09
LATEST ACTION
2018-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMLODIPINE BESYLATEDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE · TABLET · ORAL
AMLODIPINE BESYLATEDiscontinued
AMLODIPINE BESYLATE EQ 2.5MG BASE · TABLET · ORAL
AMLODIPINE BESYLATEDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE · TABLET · ORAL

Approval history

2018-04-02Labeling · Supplement 6 · standardAP
2015-09-18Labeling · Supplement 5 · standardAP
2014-09-25Labeling · Supplement 4 · standardAP
2012-01-20Labeling · Supplement 2AP
2010-04-13Labeling · Supplement 1AP
2007-07-09OriginalAP
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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