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Last Updated: September 28, 2021

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Details for New Drug Application (NDA): 021409

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NDA 021409 describes SINGULAIR, which is a drug marketed by Merck and Msd Merck Co 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-two 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 Merck Sharp & Dohme Corp. 0006-3841 0006-3841-14 4 PACKET in 1 CARTON (0006-3841-14) > 1 GRANULE in 1 PACKET
SINGULAIR montelukast sodium GRANULE;ORAL 021409 NDA Merck Sharp & Dohme Corp. 0006-3841 0006-3841-30 30 PACKET in 1 CARTON (0006-3841-30) > 1 GRANULE in 1 PACKET
Paragraph IV (Patent) Challenges for 021409
Tradename Dosage Ingredient NDA Submissiondate
SINGULAIR GRANULE;ORAL montelukast sodium 021409 2008-10-17

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrengthEQ 4MG BASE/PACKET
Approval Date:Jul 26, 2002TE:ABRLD:Yes
Patent:⤷  Free Forever TrialPatent Expiration:Oct 24, 2022Product Flag?YSubstance Flag?Delist Request?

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