← FDA Drug Approvals (Drugs@FDA)

MONTELUKAST SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2014-09-11

Drug application

FDA Application #

ANDA203366

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

MACLEODS PHARMS LTD

Manufacturer

BluePoint Laboratories

First approval

2014-09-11

Source

Authoritative

Drugs@FDA application overview

Machine

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