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FDA ANDA · ANDA207016

TELMISARTAN

Sponsor: MICRO LABS

APPLICATION
ANDA207016
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-03
LATEST ACTION
2023-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2023-06-08Labeling · Supplement 10 · standardAP
2019-11-04Labeling · Supplement 4 · standardAP
2019-11-04Labeling · Supplement 2 · standardAP
2017-10-03UNKNOWN · Original · standard — 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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