ACCOLATE

Product NDC

49884-010

11-digit product format

498840010

Labeler code

49884

Product ID

49884-010_f8196ea6-8746-4266-9693-4dca9856b558

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

zafirlukast

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Par Pharmaceutical Inc.

Application

NDA020547

Marketing category

NDA

Marketing start

2015-01-09

Marketing end

2019-04-30

Substance

ZAFIRLUKAST

Active strength

10 mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record