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MONTELUKAST SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2012-08-03

Drug application

FDA Application #

ANDA202468

Application type

Abbreviated New Drug Application (Generic)

Brand name

MONTELUKAST SODIUM

Generic name

MONTELUKAST SODIUM

Active ingredients

MONTELUKAST SODIUM

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

AUROBINDO PHARMA LTD

Manufacturer

Rising Pharma Holdings, Inc.

First approval

2012-08-03

Source

Authoritative

Drugs@FDA application overview

Machine

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