APPLICATION
ANDA078477
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-16
LATEST ACTION
2018-04-05
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
2018-04-05Labeling · Supplement 19 · standardAP
2015-11-24Labeling · Supplement 18 · standardAP
2014-09-26Labeling · Supplement 16 · standardAP
2011-11-01Manufacturing (CMC) · Supplement 12AP
2011-11-01Manufacturing (CMC) · Supplement 6AP
2011-11-01Labeling · Supplement 5AP
2011-07-26Labeling · Supplement 13AP
2010-05-27Labeling · Supplement 9AP
2008-01-16OriginalAP
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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