APPLICATION
ANDA209601
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-02
LATEST ACTION
2025-01-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TERIFLUNOMIDEDiscontinued
TERIFLUNOMIDE 7MG · TABLET · ORAL
TERIFLUNOMIDEDiscontinued
TERIFLUNOMIDE 14MG · TABLET · ORAL
Approval history
2025-01-29Labeling · Supplement 7 · standardAP
2021-12-22Labeling · Supplement 4 · standardAP
2021-12-22Labeling · Supplement 3 · standardAP
2020-07-18Labeling · Supplement 2 · standardAP
2020-07-18Labeling · Supplement 1 · standardAP
2018-11-02UNKNOWN · 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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