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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Merck
Baxter
Chubb
UBS
Boehringer Ingelheim
QuintilesIMS
Moodys
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Generated: April 22, 2018

DrugPatentWatch Database Preview

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 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-four drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for 021409
Tradename:SINGULAIR
Applicant:Merck
Ingredient:montelukast sodium
Patents:1
Therapeutic Class:Respiratory Tract Agents
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 N 0006-3841-30
SINGULAIR montelukast sodium GRANULE;ORAL 021409 NDA Merck Sharp & Dohme Corp. 0006-3841 N 0006-3841-14

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
US Department of Justice
Medtronic
Citi
Daiichi Sankyo
Moodys
Julphar
Argus Health
Dow

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