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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 078605


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NDA 078605 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 Generics, Graviti Pharms, and L Perrigo Co, and is included in forty-nine NDAs. It is available from forty-one 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-two suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for 078605
Tradename:MONTELUKAST SODIUM
Applicant:Teva Pharms
Ingredient:montelukast sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078605
Suppliers and Packaging for NDA: 078605
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 078605 ANDA Proficient Rx LP 63187-289 63187-289-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-289-30)

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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