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FDA ANDA · ANDA209600
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Sponsor: ACCORD HLTHCARE INC
APPLICATION
ANDA209600
TYPE
ANDA
ORIGINAL APPROVAL
2018-08-30
LATEST ACTION
2025-05-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMLODIPINE AND OLMESARTAN MEDOXOMILDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, OLMESARTAN MEDOXOMIL 40MG · 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 10MG BASE, OLMESARTAN MEDOXOMIL 20MG · TABLET · ORAL
Approval history
2025-05-08Labeling · Supplement 2 · standardAP
2018-08-30UNKNOWN · Original · 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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