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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
Federal Trade Commission
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Johnson and Johnson
Julphar
Healthtrust
Teva
Covington

Generated: December 18, 2017

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

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 0310-0411-60 60 TABLET, FILM COATED in 1 BOTTLE (0310-0411-60)
ACCOLATE zafirlukast TABLET;ORAL 020547 NDA AstraZeneca Pharmaceuticals LP 0310-0412 0310-0412-60 60 TABLET, FILM COATED in 1 BOTTLE (0310-0412-60)

Summary for product number 001

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 020547

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Par Pharm IncACCOLATEzafirlukastTABLET;ORAL020547-001Sep 26, 1996► Subscribe► Subscribe
Par Pharm IncACCOLATEzafirlukastTABLET;ORAL020547-001Sep 26, 1996► Subscribe► Subscribe
Par Pharm IncACCOLATEzafirlukastTABLET;ORAL020547-003Sep 17, 1999► Subscribe► Subscribe
Par Pharm IncACCOLATEzafirlukastTABLET;ORAL020547-001Sep 26, 1996► Subscribe► Subscribe
Par Pharm IncACCOLATEzafirlukastTABLET;ORAL020547-003Sep 17, 1999► Subscribe► Subscribe
Par Pharm IncACCOLATEzafirlukastTABLET;ORAL020547-003Sep 17, 1999► Subscribe► Subscribe
Par Pharm IncACCOLATEzafirlukastTABLET;ORAL020547-001Sep 26, 1996► Subscribe► Subscribe
Par Pharm IncACCOLATEzafirlukastTABLET;ORAL020547-003Sep 17, 1999► Subscribe► Subscribe
Par Pharm IncACCOLATEzafirlukastTABLET;ORAL020547-003Sep 17, 1999► Subscribe► Subscribe
Par Pharm IncACCOLATEzafirlukastTABLET;ORAL020547-001Sep 26, 1996► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Queensland Health
QuintilesIMS
Dow
Express Scripts
Fuji
Cipla
AstraZeneca
Accenture
US Department of Justice
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.

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