← FDA Drug Approvals (Drugs@FDA)

LEFLUNOMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AET PHARMA · Approved 2021-05-10

Drug application

FDA Application #

ANDA213497

Application type

Abbreviated New Drug Application (Generic)

Brand name

LEFLUNOMIDE

Generic name

LEFLUNOMIDE

Active ingredients

LEFLUNOMIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

AET PHARMA

Manufacturer

Burel Pharmaceuticals, LLC

First approval

2021-05-10

Source

Authoritative

Drugs@FDA application overview

Machine

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