Montelukast sodium chewable

Product NDC

59746-358

11-digit product format

597460358

Labeler code

59746

Product ID

59746-358_758593f9-d960-4ac8-8ada-02aeae115244

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

montelukast sodium

Dosage form

TABLET, CHEWABLE

Route

ORAL

Labeler

Jubilant Cadista Pharmaceuticals Inc.

Application

ANDA203795

Marketing category

ANDA

Marketing start

2015-02-28

Marketing end

0000-00-00

Substance

MONTELUKAST SODIUM

Active strength

4 mg/1

Pharmacologic classes

Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record