APPLICATION
ANDA078226
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-09
LATEST ACTION
2018-03-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMLODIPINE BESYLATEPrescription
AMLODIPINE BESYLATE EQ 10MG BASE · TABLET · ORAL
AMLODIPINE BESYLATEPrescription
AMLODIPINE BESYLATE EQ 2.5MG BASE · TABLET · ORAL
AMLODIPINE BESYLATEPrescription
AMLODIPINE BESYLATE EQ 5MG BASE · TABLET · ORAL
Approval history
2018-03-14Labeling · Supplement 16 · standardAP
2018-03-14Labeling · Supplement 15 · standardAP
2015-10-07Labeling · Supplement 13 · standardAP
2014-11-21Labeling · Supplement 11 · standardAP
2011-11-28Labeling · Supplement 10AP
2011-05-31Labeling · Supplement 9AP
2010-05-11Labeling · Supplement 6AP
2008-10-14Labeling · Supplement 4AP
2008-02-19Labeling · Supplement 2AP
2007-07-09OriginalAP
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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