Leflunomide

Product NDC

13811-678

11-digit product format

138110678

Labeler code

13811

Product ID

13811-678_a664123b-9725-4c37-8856-55e2304b9ecf

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Leflunomide

Dosage form

TABLET

Route

ORAL

Labeler

Trigen Laboratories, LLC

Application

ANDA091369

Marketing category

ANDA

Marketing start

2011-05-06

Marketing end

2019-12-31

Substance

LEFLUNOMIDE

Active strength

20 mg/1

Pharmacologic classes

Antirheumatic Agent [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record