ZYFLO CR

Product NDC

10122-902

11-digit product format

101220902

Labeler code

10122

Product ID

10122-902_66955d15-d2e7-4513-abb1-dfb8c8aae090

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

zileuton

Dosage form

TABLET, MULTILAYER, EXTENDED RELEASE

Route

ORAL

Labeler

Chiesi USA, Inc.

Application

NDA022052

Marketing category

NDA

Marketing start

2007-05-30

Marketing end

0000-00-00

Substance

ZILEUTON

Active strength

600 mg/1

Pharmacologic classes

5-Lipoxygenase Inhibitors [MoA],Decreased Leukotriene Production [PE],5-Lipoxygenase Inhibitor [EPC]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record