Details for New Drug Application (NDA): 020830

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NDA 020830 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-six suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.

Summary for 020830

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

Pharmacology for NDA: 020830

Mechanism of Action	Leukotriene Receptor Antagonists

Suppliers and Packaging for NDA: 020830

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830	NDA	Organon LLC	78206-170	78206-170-01	30 TABLET, CHEWABLE in 1 BOTTLE (78206-170-01)
SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830	NDA	Organon LLC	78206-173	78206-173-01	30 TABLET, CHEWABLE in 1 BOTTLE (78206-173-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 5MG BASE
Approval Date:	Feb 20, 1998	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 4MG BASE
Approval Date:	Mar 3, 2000	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020830

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-002	Mar 3, 2000	5,565,473*PED	⤷ Get Started Free
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-001	Feb 20, 1998	5,565,473*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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