APPLICATION
ANDA209677
TYPE
ANDA
ORIGINAL APPROVAL
2020-06-17
LATEST ACTION
2025-03-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TERIFLUNOMIDEPrescription
TERIFLUNOMIDE 7MG · TABLET · ORAL
TERIFLUNOMIDEPrescription
TERIFLUNOMIDE 14MG · TABLET · ORAL
Approval history
2025-03-07Labeling · Supplement 3 · standardAP
2025-03-07Labeling · Supplement 2 · standardAP
2020-06-17UNKNOWN · 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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