APPLICATION
ANDA209638
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-26
LATEST ACTION
2024-12-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TERIFLUNOMIDEPrescription
TERIFLUNOMIDE 7MG · TABLET · ORAL
TERIFLUNOMIDEPrescription
TERIFLUNOMIDE 14MG · TABLET · ORAL
Approval history
2024-12-26Labeling · Supplement 9 · standardAP
2024-12-26Labeling · Supplement 8 · standardAP
2023-03-16Manufacturing (CMC) · Supplement 7 · standardAP
2022-11-02Labeling · Supplement 5 · standardAP
2022-11-02Labeling · Supplement 6 · standardAP
2021-04-07Labeling · Supplement 4 · standardAP
2020-06-23Labeling · Supplement 3 · standardAP
2019-11-29Labeling · Supplement 1 · standardAP
2019-11-29Labeling · Supplement 2 · standardAP
2018-10-26UNKNOWN · 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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