APPLICATION
ANDA201380
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-13
LATEST ACTION
2026-02-17
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
2026-02-17Manufacturing (CMC) · Supplement 23 · unknownAP
2026-01-26Manufacturing (CMC) · Supplement 22 · unknownAP
2023-06-07Labeling · Supplement 17 · standardAP
2018-04-03Labeling · Supplement 7 · standardAP
2015-12-03Labeling · Supplement 5 · standardAP
2014-09-19Labeling · Supplement 2 · standardAP
2012-04-13UNKNOWN · OriginalAP
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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