APPLICATION
ANDA201586
TYPE
ANDA
ORIGINAL APPROVAL
2014-01-08
LATEST ACTION
2019-05-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TELMISARTAN AND AMLODIPINEDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, TELMISARTAN 80MG · TABLET · ORAL
TELMISARTAN AND AMLODIPINEDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, TELMISARTAN 40MG · TABLET · ORAL
TELMISARTAN AND AMLODIPINEDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE, TELMISARTAN 80MG · TABLET · ORAL
TELMISARTAN AND AMLODIPINEDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE, TELMISARTAN 40MG · TABLET · ORAL
Approval history
2019-05-07Labeling · Supplement 6 · standardAP
2016-09-02Labeling · Supplement 2 · standardAP
2016-09-02Labeling · Supplement 3 · 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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