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Generated: August 21, 2018

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Details for New Drug Application (NDA): 202468

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NDA 202468 describes MONTELUKAST SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Mylan Pharms Inc, Teva Pharms, Torrent Pharms Llc, 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, Unichem Labs Ltd, Unimark Remedies Ltd, Vintage Pharms Llc, West-ward Pharms Int, Accord Hlthcare, Amneal Pharms, Apotex Corp, Cipla Ltd, Glenmark Generics, and Perrigo R And D, and is included in forty-five 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-four 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 202468
Tradename:MONTELUKAST SODIUM
Applicant:Aurobindo Pharma Ltd
Ingredient:montelukast sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202468
Suppliers and Packaging for NDA: 202468
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 202468 ANDA LUCID PHARMA LLC 52343-037 N 52343-037-30
MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 202468 ANDA LUCID PHARMA LLC 52343-037 N 52343-037-90

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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