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Last Updated: July 5, 2020

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Details for New Drug Application (NDA): 020830


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NDA 020830 describes SINGULAIR, which is a drug marketed by Merck and Msd Merck Co and is included in three NDAs. It is available from two suppliers. 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. Forty-one suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for 020830
Tradename:SINGULAIR
Applicant:Msd Merck Co
Ingredient:montelukast sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020830
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 Merck Sharp & Dohme Corp. 0006-1711 0006-1711-31 30 TABLET, CHEWABLE in 1 BOTTLE (0006-1711-31)
SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830 NDA Merck Sharp & Dohme Corp. 0006-9275 0006-9275-31 30 TABLET, CHEWABLE in 1 BOTTLE (0006-9275-31)
Paragraph IV (Patent) Challenges for 020830
Tradename Dosage Ingredient NDA Submissiondate
SINGULAIR TABLET, CHEWABLE;ORAL montelukast sodium 020830 2006-12-26

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 5MG BASE
Approval Date:Feb 20, 1998TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 4MG BASE
Approval Date:Mar 3, 2000TE:ABRLD:Yes

Expired US Patents for NDA 020830

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998   Start Trial   Start Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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