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FDA ANDA · ANDA077516

AMLODIPINE BESYLATE

Sponsor: STRIDES PHARMA

APPLICATION
ANDA077516
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-11
LATEST ACTION
2018-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2018-04-23Labeling · Supplement 4 · standardAP
2015-10-28Manufacturing (CMC) · Supplement 1 · unknownAP
2007-07-11OriginalAP
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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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