← FDA Drug Approvals (Drugs@FDA)

LEFLUNOMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN · Approved 2020-02-04

Drug application

FDA Application #

ANDA211863

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

LUPIN

Manufacturer

Lupin Pharmaceuticals, Inc.

First approval

2020-02-04

Source

Authoritative

Drugs@FDA application overview

Machine

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