← FDA Drug Approvals (Drugs@FDA)

MONTELUKAST SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2020-02-18

Drug application

FDA Application #

ANDA213471

Application type

Abbreviated New Drug Application (Generic)

Brand name

MONTELUKAST SODIUM

Generic name

MONTELUKAST SODIUM

Active ingredients

MONTELUKAST SODIUM

Dosage form

GRANULE

Route

ORAL

Marketing status

Prescription

Sponsor

AUROBINDO PHARMA LTD

Manufacturer

Aurobindo Pharma Limited

First approval

2020-02-18

Source

Authoritative

Drugs@FDA application overview

Machine

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