APPLICATION
ANDA090011
TYPE
ANDA
ORIGINAL APPROVAL
2013-03-28
LATEST ACTION
2016-02-05
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
2016-02-05Labeling · Supplement 4 · standardAP
2016-02-05Labeling · Supplement 5 · standardAP
2014-11-14Manufacturing (CMC) · Supplement 2 · unknownAP
2014-09-24Labeling · Supplement 1 · 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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