← FDA Drug Approvals (Drugs@FDA)

LEFLUNOMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS LIFESCIENCES · Approved 2019-04-24

Drug application

FDA Application #

ANDA212308

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

ZYDUS LIFESCIENCES

Manufacturer

Zydus Lifesciences Limited

First approval

2019-04-24

Source

Authoritative

Drugs@FDA application overview

Machine

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