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Generated: January 21, 2019

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Details for New Drug Application (NDA): 020829

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NDA 020829 describes SINGULAIR, which is a drug marketed by Merck and Msd Merck Co and is included in three NDAs. It is available from five 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. Fifty-eight suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for 020829
Tradename:SINGULAIR
Applicant:Msd Merck Co
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 Merck Sharp & Dohme Corp. 0006-9117 0006-9117-31 30 TABLET, FILM COATED in 1 BOTTLE (0006-9117-31)
SINGULAIR montelukast sodium TABLET;ORAL 020829 NDA Merck Sharp & Dohme Corp. 0006-9117 0006-9117-54 90 TABLET, FILM COATED in 1 BOTTLE (0006-9117-54)

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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