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Serving leading biopharmaceutical companies globally:

Farmers Insurance
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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204093

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NDA 204093 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-five 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-eight suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for 204093
Tradename:MONTELUKAST SODIUM
Applicant:Hetero Labs Ltd V
Ingredient:montelukast sodium
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204093
Suppliers and Packaging for NDA: 204093
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 204093 ANDA Camber Pharmaceuticals, Inc. 31722-727 31722-727-32 100 TABLET, CHEWABLE in 1 CARTON (31722-727-32)
MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 204093 ANDA Camber Pharmaceuticals, Inc. 31722-727 31722-727-30 30 TABLET, CHEWABLE in 1 BOTTLE (31722-727-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 4MG BASE
Approval Date:May 22, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 5MG BASE
Approval Date:May 22, 2015TE:ABRLD:No

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Chinese Patent Office
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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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