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FDA ANDA · ANDA076846

AMLODIPINE BESYLATE

Sponsor: TEVA

APPLICATION
ANDA076846
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-28
LATEST ACTION
2018-03-14
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

2018-03-14Labeling · Supplement 16 · standardAP
2015-10-01Labeling · Supplement 14 · standardAP
2013-08-30Labeling · Supplement 12 · standardAP
2013-05-02Manufacturing (CMC) · Supplement 13 · unknownAP
2011-12-31Labeling · Supplement 10AP
2011-07-27Labeling · Supplement 8AP
2010-04-09Labeling · Supplement 7AP
2009-03-12Labeling · Supplement 6AP
2008-04-14Labeling · Supplement 4AP
2007-08-30Labeling · Supplement 1AP
2007-06-28OriginalAP
VIEW ON DRUGS@FDA ↗

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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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