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FDA ANDA · ANDA077974

AMLODIPINE BESYLATE

Sponsor: SUN PHARM INDS LTD

APPLICATION
ANDA077974
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-09
LATEST ACTION
2018-04-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMLODIPINE BESYLATEDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE · TABLET · ORAL
AMLODIPINE BESYLATEDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE · TABLET · ORAL
AMLODIPINE BESYLATEDiscontinued
AMLODIPINE BESYLATE EQ 2.5MG BASE · TABLET · ORAL

Approval history

2018-04-03Labeling · Supplement 5 · standardAP
2018-04-03Labeling · Supplement 4 · standardAP
2015-10-06Labeling · Supplement 3 · standardAP
2014-09-21Labeling · Supplement 2 · standardAP
2007-07-09OriginalAP
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Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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