APPLICATION
ANDA078925
TYPE
ANDA
ORIGINAL APPROVAL
2009-05-04
LATEST ACTION
2025-01-03
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
2025-01-03Manufacturing (CMC) · Supplement 25 · unknownAP
2017-10-02Labeling · Supplement 10 · standardAP
2015-11-24Labeling · Supplement 7 · standardAP
2014-09-21Labeling · Supplement 5 · standardAP
2013-07-09Manufacturing (CMC) · Supplement 2AP
2010-04-20Labeling · Supplement 1AP
2009-05-04OriginalAP
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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