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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 203438


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NDA 203438 describes MONTELUKAST SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Norvium Bioscience, Teva Pharms, Torrent, Amneal Pharms, Anbison Lab, Apotex Inc, Chartwell Molecular, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Natco Pharma, Rising, Sandoz Inc, Strides Pharma, Torrent Pharms Ltd, Unichem, Unimark Remedies Ltd, Accord Hlthcare, Apotex Corp, Breckenridge, Cipla, Glenmark Pharms Ltd, and L Perrigo Co, and is included in forty-nine NDAs. It is available from thirty-nine 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 suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for 203438
Tradename:MONTELUKAST SODIUM
Applicant:Ajanta Pharma Ltd
Ingredient:montelukast sodium
Patents:0
Pharmacology for NDA: 203438
Suppliers and Packaging for NDA: 203438
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONTELUKAST SODIUM montelukast sodium GRANULE;ORAL 203438 ANDA Ajanta Pharma USA Inc. 27241-015 27241-015-31 30 GRANULE in 1 CARTON (27241-015-31)

Profile for product number 001

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

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