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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 three suppliers. Additional details are available on the ACCOLATE profile page.

The generic ingredient in ACCOLATE is zafirlukast. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the zafirlukast profile page.

Summary for NDA: 020547

Tradename:
ACCOLATE
Applicant:
Par Pharm Inc
Ingredient:
zafirlukast
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 0310-0401 0310-0401-60 60 TABLET, FILM COATED in 1 BOTTLE (0310-0401-60)
ACCOLATE
zafirlukast
TABLET;ORAL 020547 NDA AstraZeneca Pharmaceuticals LP 0310-0402 0310-0402-60 60 TABLET, FILM COATED in 1 BOTTLE (0310-0402-60)

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:No

Expired Orange Book Patents for NDA: 020547

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Par Pharm Inc
ACCOLATE
zafirlukast
TABLET;ORAL020547-001Sep 26, 19965,319,097► subscribe
Par Pharm Inc
ACCOLATE
zafirlukast
TABLET;ORAL020547-003Sep 17, 19996,143,775► subscribe
Par Pharm Inc
ACCOLATE
zafirlukast
TABLET;ORAL020547-001Sep 26, 19964,859,692► subscribe
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