← FDA Drug Approvals (Drugs@FDA)

MONTELUKAST SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UNICHEM · Approved 2018-07-02

Drug application

FDA Application #

ANDA208621

Application type

Abbreviated New Drug Application (Generic)

Brand name

MONTELUKAST SODIUM

Generic name

MONTELUKAST SODIUM

Active ingredients

MONTELUKAST SODIUM

Dosage form

TABLET, CHEWABLE

Route

ORAL

Marketing status

Prescription

Sponsor

UNICHEM

Manufacturer

Unichem Pharmaceuticals (USA), Inc.

First approval

2018-07-02

Source

Authoritative

Drugs@FDA application overview

Machine

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