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Last Updated: February 29, 2024

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. It is available from one supplier. 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. Forty-two 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
Pharmacology for NDA: 020829
Suppliers and Packaging for NDA: 020829
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SINGULAIR montelukast sodium TABLET;ORAL 020829 NDA Organon LLC 78206-172 78206-172-01 30 TABLET, FILM COATED in 1 BOTTLE (78206-172-01)
SINGULAIR montelukast sodium TABLET;ORAL 020829 NDA Organon LLC 78206-172 78206-172-02 90 TABLET, FILM COATED in 1 BOTTLE (78206-172-02)

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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