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FDA ANDA · ANDA207292

AMLODIPINE AND VALSARTAN

Sponsor: MACLEODS PHARMS LTD

APPLICATION
ANDA207292
TYPE
ANDA
ORIGINAL APPROVAL
2024-10-11
LATEST ACTION
2024-10-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AMLODIPINE BESYLATE AND VALSARTANPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, VALSARTAN 320MG · TABLET · ORAL
AMLODIPINE BESYLATE AND VALSARTANPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, VALSARTAN 160MG · TABLET · ORAL
AMLODIPINE BESYLATE AND VALSARTANPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, VALSARTAN 320MG · TABLET · ORAL
AMLODIPINE BESYLATE AND VALSARTANPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, VALSARTAN 160MG · TABLET · ORAL

Approval history

2024-10-11UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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