Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Boehringer Ingelheim
Argus Health

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021409

« Back to Dashboard

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
Ingredient:montelukast sodium
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?

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo
Argus Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.