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Last Updated: March 29, 2024

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. Forty-two 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021409
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:RXDosage:GRANULE;ORALStrengthEQ 4MG BASE/PACKET
Approval Date:Jul 26, 2002TE:ABRLD:Yes

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