APPLICATION
ANDA203867
TYPE
ANDA
ORIGINAL APPROVAL
2014-11-03
LATEST ACTION
2019-05-17
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
2019-05-17Labeling · Supplement 7 · standardAP
2015-11-17Labeling · Supplement 4 · standardAP
2015-11-17Labeling · Supplement 2 · standardAP
2014-11-03UNKNOWN · 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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