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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020547

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NDA 020547 describes ACCOLATE, which is a drug marketed by Par Pharm Inc and is included in one NDA. It is available from five suppliers. Additional details are available on the ACCOLATE profile page.

The generic ingredient in ACCOLATE is zafirlukast. There are three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the zafirlukast profile page.
Summary for 020547
Applicant:Par Pharm Inc
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020547
Suppliers and Packaging for NDA: 020547
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACCOLATE zafirlukast TABLET;ORAL 020547 NDA AstraZeneca Pharmaceuticals LP 0310-0411 N 0310-0411-60
ACCOLATE zafirlukast TABLET;ORAL 020547 NDA AstraZeneca Pharmaceuticals LP 0310-0412 N 0310-0412-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Sep 26, 1996TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 17, 1999TE:ABRLD:Yes

Expired US Patents for NDA 020547

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
Fish and Richardson
Chinese Patent Office
US Department of Justice

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