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FDA ANDA · ANDA077771

AMLODIPINE BESYLATE

Sponsor: HIKMA PHARMS

APPLICATION
ANDA077771
TYPE
ANDA
ORIGINAL APPROVAL
2011-04-12
LATEST ACTION
2023-02-27
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

2023-02-27Labeling · Supplement 7 · standardAP
2015-09-25Labeling · Supplement 5 · standardAP
2015-09-25Labeling · Supplement 4 · standardAP
2011-11-18Labeling · Supplement 3AP
2011-04-12OriginalAP
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Related on SPEQ

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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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