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FDA ANDA · ANDA202933

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Sponsor: TORRENT

APPLICATION
ANDA202933
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-25
LATEST ACTION
2023-06-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMLODIPINE AND OLMESARTAN MEDOXOMILDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE, OLMESARTAN MEDOXOMIL 20MG · TABLET · ORAL
AMLODIPINE AND OLMESARTAN MEDOXOMILDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, OLMESARTAN MEDOXOMIL 20MG · TABLET · ORAL
AMLODIPINE AND OLMESARTAN MEDOXOMILDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
AMLODIPINE AND OLMESARTAN MEDOXOMILDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL

Approval history

2023-06-27Labeling · Supplement 13 · standardAP
2019-10-24Labeling · Supplement 2 · standardAP
2016-11-25UNKNOWN · OriginalAP
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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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