APPLICATION
ANDA078453
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-02
LATEST ACTION
2018-04-25
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
2018-04-25Labeling · Supplement 6 · standardAP
2018-04-25Labeling · Supplement 5 · standardAP
2015-10-07Labeling · Supplement 4 · standardAP
2014-10-26Labeling · Supplement 2AP
2014-10-26Labeling · Supplement 3 · standardAP
2011-08-29Labeling · Supplement 1AP
2009-07-02OriginalAP
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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