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Last Updated: June 9, 2023

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. 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-three suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for 021409
Ingredient:montelukast sodium
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
Patent:⤷  Try a TrialPatent Expiration:Oct 24, 2022Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson

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