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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 021409

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NDA 021409 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.

Summary for 021409

Tradename:	SINGULAIR
Applicant:	Organon
Ingredient:	montelukast sodium
Patents:	0

Pharmacology for NDA: 021409

Mechanism of Action	Leukotriene Receptor Antagonists

Suppliers and Packaging for NDA: 021409

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SINGULAIR	montelukast sodium	GRANULE;ORAL	021409	NDA	Organon LLC	78206-171	78206-171-01	30 PACKET in 1 CARTON (78206-171-01) / 1 GRANULE in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GRANULE;ORAL			Strength	EQ 4MG BASE/PACKET
Approval Date:	Jul 26, 2002	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021409

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	SINGULAIR	montelukast sodium	GRANULE;ORAL	021409-001	Jul 26, 2002	5,565,473*PED	⤷ Get Started Free
Organon	SINGULAIR	montelukast sodium	GRANULE;ORAL	021409-001	Jul 26, 2002	8,007,830	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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