APPLICATION
ANDA076719
TYPE
ANDA
ORIGINAL APPROVAL
2007-05-23
LATEST ACTION
2018-04-02
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
2018-04-02Labeling · Supplement 11 · standardAP
2015-09-25Labeling · Supplement 10 · standardAP
2013-08-26Labeling · Supplement 9 · standardAP
2013-08-26Labeling · Supplement 8 · standardAP
2011-03-22Labeling · Supplement 6AP
2007-05-23OriginalAP
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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