APPLICATION
ANDA090032
TYPE
ANDA
ORIGINAL APPROVAL
2014-07-07
LATEST ACTION
2023-04-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TELMISARTANPrescription
TELMISARTAN 20MG · TABLET · ORAL
TELMISARTANPrescription
TELMISARTAN 40MG · TABLET · ORAL
TELMISARTANPrescription
TELMISARTAN 80MG · TABLET · ORAL
Approval history
2023-04-25Labeling · Supplement 12 · standardAP
2021-10-15Manufacturing (CMC) · Supplement 6AP
2021-03-16Labeling · Supplement 5 · standardAP
2015-11-17Labeling · Supplement 2 · standardAP
2014-07-07OriginalAP
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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