APPLICATION
ANDA078021
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-17
LATEST ACTION
2018-03-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMLODIPINE BESYLATEPrescription
AMLODIPINE BESYLATE EQ 5MG BASE · TABLET · ORAL
AMLODIPINE BESYLATEPrescription
AMLODIPINE BESYLATE EQ 10MG BASE · TABLET · ORAL
AMLODIPINE BESYLATEPrescription
AMLODIPINE BESYLATE EQ 2.5MG BASE · TABLET · ORAL
Approval history
2018-03-14Labeling · Supplement 12 · standardAP
2018-03-14Labeling · Supplement 13 · standardAP
2015-09-17Labeling · Supplement 11 · standardAP
2014-09-26Labeling · Supplement 9 · standardAP
2011-12-31Labeling · Supplement 8AP
2011-08-31Labeling · Supplement 7AP
2010-06-30Labeling · Supplement 4AP
2008-10-21Labeling · Supplement 3AP
2007-07-17OriginalAP
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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