ACCOLATE

Product NDC

53808-0203

11-digit product format

538080203

Labeler code

53808

Product ID

53808-0203_9798152d-b3b5-4fc6-985e-10b59177464b

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Zafirlukast

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

State of Florida DOH Central Pharmacy

Application

NDA020547

Marketing category

NDA

Marketing start

2009-07-01

Marketing end

0000-00-00

Substance

ZAFIRLUKAST

Active strength

20 mg/1

Pharmacologic classes

Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Leukotriene Receptor Antagonist [EPC]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record