APPLICATION
ANDA209613
TYPE
ANDA
ORIGINAL APPROVAL
2018-09-28
LATEST ACTION
2025-03-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TERIFLUNOMIDEDiscontinued
TERIFLUNOMIDE 14MG · TABLET · ORAL
TERIFLUNOMIDEDiscontinued
TERIFLUNOMIDE 7MG · TABLET · ORAL
Approval history
2025-03-26Labeling · Supplement 10 · standardAP
2025-03-26Labeling · Supplement 9 · standardAP
2024-02-20Labeling · Supplement 7 · standardAP
2020-11-05Labeling · Supplement 3 · standardAP
2019-11-29Labeling · Supplement 1 · standardAP
2018-09-28UNKNOWN · 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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