← FDA Drug Approvals (Drugs@FDA)

LEFLUNOMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ABHAI LLC · Approved 2019-06-03

Drug application

FDA Application #

ANDA212453

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

ABHAI LLC

Manufacturer

KVK-Tech, Inc.

First approval

2019-06-03

Source

Authoritative

Drugs@FDA application overview

Machine

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