APPLICATION
ANDA208605
TYPE
ANDA
ORIGINAL APPROVAL
2017-07-25
LATEST ACTION
2023-12-21
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
2023-12-21Manufacturing (CMC) · Supplement 7 · unknownAP
2019-05-17Labeling · Supplement 1 · 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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