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FDA ANDA · ANDA078500

AMLODIPINE BESYLATE

Sponsor: WOCKHARDT

APPLICATION
ANDA078500
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-06
LATEST ACTION
2014-10-21
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

2014-10-21Labeling · Supplement 3 · standardAP
2007-09-06OriginalAP
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