APPLICATION
ANDA078552
TYPE
ANDA
ORIGINAL APPROVAL
2009-04-08
LATEST ACTION
2025-06-17
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
2025-06-17Labeling · Supplement 15 · standardAP
2018-04-26Labeling · Supplement 10 · standardAP
2015-10-19Labeling · Supplement 6 · standardAP
2015-01-27Manufacturing (CMC) · Supplement 3AP
2013-08-30Labeling · Supplement 4 · standardAP
2013-08-30Labeling · Supplement 5 · standardAP
2009-04-08OriginalAP
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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