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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Harvard Business School
US Department of Justice

Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090655

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NDA 090655 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-six suppliers. Additional details are available on the MONTELUKAST SODIUM profile page.

The generic ingredient in MONTELUKAST SODIUM is montelukast sodium. There are thirty-three drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for 090655
Applicant:West-ward Pharms Int
Ingredient:montelukast sodium
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090655
Suppliers and Packaging for NDA: 090655
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 090655 ANDA West-Ward Pharmaceuticals Corp. 0054-0259 N 0054-0259-13
MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 090655 ANDA West-Ward Pharmaceuticals Corp. 0054-0259 N 0054-0259-22

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Aug 3, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Chinese Patent Office
Queensland Health

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