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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Medtronic
Healthtrust
Colorcon
Chubb
Fish and Richardson
Farmers Insurance
Deloitte
Teva
Cantor Fitzgerald
Baxter

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203582

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NDA 203582 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-three 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-six suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.

Summary for 203582

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203582

Suppliers and Packaging for NDA: 203582

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 203582 ANDA Macleods Pharmaceuticals Limited 33342-110 33342-110-07 30 TABLET, CHEWABLE in 1 BOTTLE (33342-110-07)
MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 203582 ANDA Macleods Pharmaceuticals Limited 33342-110 33342-110-44 1000 TABLET, CHEWABLE in 1 BOTTLE (33342-110-44)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 4MG BASE
Approval Date:Mar 12, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 5MG BASE
Approval Date:Mar 12, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
Accenture
McKinsey
Moodys
Harvard Business School
US Army
US Department of Justice
Dow
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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