APPLICATION
ANDA206511
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-03
LATEST ACTION
2023-06-09
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
2023-06-09Labeling · Supplement 14 · standardAP
2023-06-09Labeling · Supplement 13 · standardAP
2023-06-09Labeling · Supplement 11 · standardAP
2019-04-02Labeling · Supplement 3 · 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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