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MONTELUKAST SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS · Approved 2015-09-04

Drug application

FDA Application #

ANDA204604

Application type

Abbreviated New Drug Application (Generic)

Brand name

MONTELUKAST SODIUM

Generic name

MONTELUKAST

Active ingredients

MONTELUKAST SODIUM

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

AMNEAL PHARMS

Manufacturer

Amneal Pharmaceuticals LLC

First approval

2015-09-04

Source

Authoritative

Drugs@FDA application overview

Machine

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