← FDA Drug Approvals (Drugs@FDA)

MONTELUKAST SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS · Approved 2020-09-04

Drug application

FDA Application #

ANDA205107

Application type

Abbreviated New Drug Application (Generic)

Brand name

MONTELUKAST SODIUM

Generic name

MONTELUKAST

Active ingredients

MONTELUKAST SODIUM

Dosage form

TABLET, CHEWABLE

Route

ORAL

Marketing status

Discontinued

Sponsor

AMNEAL PHARMS

Manufacturer

Amneal Pharmaceuticals LLC

First approval

2020-09-04

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown