APPLICATION
ANDA212308
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-24
LATEST ACTION
2024-09-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEFLUNOMIDEPrescription
LEFLUNOMIDE 20MG · TABLET · ORAL
LEFLUNOMIDEPrescription
LEFLUNOMIDE 10MG · TABLET · ORAL
Approval history
2024-09-26Labeling · Supplement 1 · 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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