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Last Updated: July 13, 2024

Details for New Drug Application (NDA): 209012

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NDA 209012 describes MONTELUKAST SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Mylan Pharms Inc, Teva Pharms, Torrent, Amneal Pharms, Anbison Lab, Apotex Inc, Chartwell Molecular, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Rising, Sandoz Inc, Strides Pharma, Torrent Pharms Ltd, Unichem, Unimark Remedies Ltd, Accord Hlthcare, Apotex Corp, Breckenridge, Cipla, Glenmark Pharms Ltd, Graviti Pharms, and L Perrigo Co, and is included in forty-nine NDAs. It is available from forty suppliers. Additional details are available on the MONTELUKAST SODIUM profile page.

The generic ingredient in MONTELUKAST SODIUM is montelukast sodium. There are thirty-five drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for 209012
Applicant:Graviti Pharms
Ingredient:montelukast sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 209012
Suppliers and Packaging for NDA: 209012
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 209012 ANDA Rising Pharma Holdings, Inc. 16571-100 16571-100-09 90 TABLET in 1 BOTTLE (16571-100-09)
MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 209012 ANDA Rising Pharma Holdings, Inc. 16571-100 16571-100-10 1000 TABLET in 1 BOTTLE (16571-100-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Apr 24, 2017TE:ABRLD:No

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