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FDA ANDA · ANDA202130

TELMISARTAN

Sponsor: ALEMBIC

APPLICATION
ANDA202130
TYPE
ANDA
ORIGINAL APPROVAL
2014-07-07
LATEST ACTION
2019-04-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TELMISARTANPrescription
TELMISARTAN 40MG · TABLET · ORAL
TELMISARTANPrescription
TELMISARTAN 80MG · TABLET · ORAL
TELMISARTANPrescription
TELMISARTAN 20MG · TABLET · ORAL

Approval history

2019-04-16Labeling · Supplement 8 · standardAP
2015-10-08Labeling · Supplement 2 · standardAP
2014-09-25Labeling · Supplement 1 · standardAP
2014-07-07OriginalAP
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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