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Last Updated: October 6, 2022

Details for New Drug Application (NDA): 020829


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NDA 020829 describes SINGULAIR, which is a drug marketed by Organon and is included in three NDAs. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the SINGULAIR profile page.

The generic ingredient in SINGULAIR is montelukast sodium. There are thirty-five drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for 020829
Tradename:SINGULAIR
Applicant:Organon
Ingredient:montelukast sodium
Patents:0
Formulation / Manufacturing:see details

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Feb 20, 1998TE:ABRLD:Yes

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