APPLICATION
ANDA078500
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-06
LATEST ACTION
2014-10-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMLODIPINE BESYLATEDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE · TABLET · ORAL
AMLODIPINE BESYLATEDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE · TABLET · ORAL
AMLODIPINE BESYLATEDiscontinued
AMLODIPINE BESYLATE EQ 2.5MG BASE · TABLET · ORAL
Approval history
2014-10-21Labeling · Supplement 3 · standardAP
2007-09-06OriginalAP
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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