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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203328

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NDA 203328 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 203328

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

Pharmacology for NDA: 203328

Suppliers and Packaging for NDA: 203328

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 203328 ANDA Ajanta Pharma Limited 27241-016 27241-016-09 90 TABLET, CHEWABLE in 1 BOTTLE (27241-016-09)
MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 203328 ANDA Ajanta Pharma Limited 27241-016 27241-016-03 30 TABLET, CHEWABLE in 1 BOTTLE (27241-016-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 4MG BASE
Approval Date:Jul 31, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 5MG BASE
Approval Date:Jul 31, 2015TE:ABRLD:No


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