APPLICATION
ANDA207882
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-03
LATEST ACTION
2023-06-26
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
2023-06-26Labeling · Supplement 9 · standardAP
2023-03-10Labeling · Supplement 7 · standardAP
2023-03-10Labeling · Supplement 4 · standardAP
2020-04-10Labeling · Supplement 2 · standardAP
2017-05-03UNKNOWN · Original · 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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