← FDA Drug Approvals (Drugs@FDA)

LEFLUNOMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC PHARMS LTD · Approved 2011-11-21

Drug application

FDA Application #

ANDA091369

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

ALEMBIC PHARMS LTD

Manufacturer

Alembic Pharmaceuticals Limited

First approval

2011-11-21

Source

Authoritative

Drugs@FDA application overview

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