APPLICATION
ANDA077955
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-28
LATEST ACTION
2018-04-20
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
2018-04-20Labeling · Supplement 14 · standardAP
2015-12-21Labeling · Supplement 11 · standardAP
2013-08-26Labeling · Supplement 5 · standardAP
2013-08-26Labeling · Supplement 3AP
2013-08-26Labeling · Supplement 8 · standardAP
2011-02-11Labeling · Supplement 2AP
2009-12-04Labeling · Supplement 1AP
2007-08-28OriginalAP
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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