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FDA ANDA · ANDA091154
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Sponsor: TEVA PHARMS USA
APPLICATION
ANDA091154
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-26
LATEST ACTION
2019-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
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
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
Approval history
2019-10-24Labeling · Supplement 3 · standardAP
2019-10-24Labeling · Supplement 2 · standardAP
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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