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FDA ANDA · ANDA202517

TELMISARTAN AND AMLODIPINE

Sponsor: TORRENT

APPLICATION
ANDA202517
TYPE
ANDA
ORIGINAL APPROVAL
2014-01-08
LATEST ACTION
2021-10-20
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

2021-10-20Labeling · Supplement 4 · standardAP
2021-10-20Labeling · Supplement 7 · standardAP
2015-11-30Labeling · Supplement 3 · standardAP
2014-06-20Manufacturing (CMC) · Supplement 2 — Letter ↗AP
2014-01-08UNKNOWN · Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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