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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Fish and Richardson
Accenture
Merck
Julphar
Cerilliant
Dow
Baxter
Teva

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201582

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NDA 201582 describes MONTELUKAST SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Mylan Pharms Inc, Teva Pharms, Anbison Lab Co Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Hetero Labs Ltd V, Jubilant Generics, Kremers Urban Pharms, Macleods Pharms Ltd, Sandoz Inc, Torrent Pharms Ltd, Unimark Remedies Ltd, Vintage Pharms Llc, West-ward Pharms Int, Accord Hlthcare, Amneal Pharms, Apotex Corp, Cipla Ltd, Glenmark Generics, Perrigo R And D, and Unichem Labs Ltd, and is included in forty-three NDAs. It is available from fifty-one suppliers. Additional details are available on the MONTELUKAST SODIUM profile page.

The generic ingredient in MONTELUKAST SODIUM is montelukast sodium. There are thirty-four drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for 201582
Tradename:MONTELUKAST SODIUM
Applicant:Dr Reddys Labs Ltd
Ingredient:montelukast sodium
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 201582
Suppliers and Packaging for NDA: 201582
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 201582 ANDA Dr.Reddy's Laboratories Limited 55111-725 N 55111-725-01
MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 201582 ANDA Dr.Reddy's Laboratories Limited 55111-725 N 55111-725-78

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Aug 6, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Fish and Richardson
Argus Health
Dow
US Army
Moodys
McKesson
Teva
Cerilliant

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