FIBRICOR

Product NDC

49708-102

11-digit product format

497080102

Labeler code

49708

Product ID

49708-102_7a94885b-62b6-4db9-8d01-f594be8dba13

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Fenofibric Acid

Dosage form

TABLET

Route

ORAL

Labeler

Caraco Pharma, Inc.

Application

NDA022418

Marketing category

NDA

Marketing start

2009-08-14

Marketing end

0000-00-00

Substance

FENOFIBRIC ACID

Active strength

105 mg/1

Pharmacologic classes

Peroxisome Proliferator Receptor alpha Agonist [EPC]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record