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Julphar
US Department of Justice
Cantor Fitzgerald
Chinese Patent Office
Baxter
McKinsey
Harvard Business School
Cerilliant
Moodys

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090955

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NDA 090955 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, Lannett Co Inc, 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-seven 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. Sixty suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for 090955
Tradename:MONTELUKAST SODIUM
Applicant:Teva Pharms
Ingredient:montelukast sodium
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090955
Suppliers and Packaging for NDA: 090955
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONTELUKAST SODIUM montelukast sodium GRANULE;ORAL 090955 ANDA Teva Pharmaceuticals USA, Inc. 0093-7487 N 0093-7487-56

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrengthEQ 4MG BASE/PACKET
Approval Date:Aug 3, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Farmers Insurance
Accenture
Teva
Julphar
Medtronic
Dow
McKesson
UBS

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