APPLICATION
ANDA202516
TYPE
ANDA
ORIGINAL APPROVAL
2014-08-26
LATEST ACTION
2019-09-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TELMISARTAN AND AMLODIPINEPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, TELMISARTAN 80MG · TABLET · ORAL
TELMISARTAN AND AMLODIPINEPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, TELMISARTAN 40MG · TABLET · ORAL
TELMISARTAN AND AMLODIPINEPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, TELMISARTAN 80MG · TABLET · ORAL
TELMISARTAN AND AMLODIPINEPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, TELMISARTAN 40MG · TABLET · ORAL
Approval history
2019-09-09Labeling · Supplement 6 · standardAP
2019-09-09Labeling · Supplement 4 · standardAP
2015-11-17Labeling · Supplement 3 · standardAP
2015-01-02Labeling · Supplement 1 · standardAP
2014-08-26UNKNOWN · OriginalAP
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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