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FDA ANDA · ANDA205234

TELMISARTAN AND AMLODIPINE

Sponsor: ALEMBIC

APPLICATION
ANDA205234
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-17
LATEST ACTION
2016-11-17
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

2016-11-17UNKNOWN · Original · standardLetterAP
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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