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FDA ANDA · ANDA209591
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Sponsor: HETERO LABS LTD V
APPLICATION
ANDA209591
TYPE
ANDA
ORIGINAL APPROVAL
2025-02-14
LATEST ACTION
2025-02-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMLODIPINE AND OLMESARTAN MEDOXOMILPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
AMLODIPINE AND OLMESARTAN MEDOXOMILPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
AMLODIPINE AND OLMESARTAN MEDOXOMILPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, OLMESARTAN MEDOXOMIL 20MG · TABLET · ORAL
AMLODIPINE AND OLMESARTAN MEDOXOMILPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, OLMESARTAN MEDOXOMIL 20MG · TABLET · ORAL
Approval history
2025-02-14UNKNOWN · 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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