APPLICATION
ANDA203325
TYPE
ANDA
ORIGINAL APPROVAL
2014-08-26
LATEST ACTION
2023-03-21
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
2023-03-21Labeling · Supplement 11 · standardAP
2019-04-16Labeling · Supplement 3 · standardAP
2015-12-04Labeling · Supplement 1 · standardAP
2014-08-26UNKNOWN · OriginalAP
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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