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FDA ANDA · ANDA209549

TERIFLUNOMIDE

Sponsor: WATSON LABS TEVA

APPLICATION
ANDA209549
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-27
LATEST ACTION
2022-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TERIFLUNOMIDEDiscontinued
TERIFLUNOMIDE 7MG · TABLET · ORAL
TERIFLUNOMIDEDiscontinued
TERIFLUNOMIDE 14MG · TABLET · ORAL

Approval history

2022-12-01Labeling · Supplement 2 · standardAP
2022-12-01Labeling · Supplement 1 · standardAP
2018-07-27UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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