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Profile for Tradename: ACCOLATE

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Accolate is a drug marketed by Astrazeneca and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

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

Summary for Tradename: ACCOLATE

Patents:1
Applicants:1
NDAs:1
Suppliers: see list3

Pharmacology for Tradename: ACCOLATE

Clinical Trials for: ACCOLATE

Bioequivalence Study of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
Status: Completed Condition: Healthy

A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy
Status: Completed Condition: Allergic Asthma

Courtesy of ClinicalTrials.org
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Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca
ACCOLATE
zafirlukast
TABLET;ORAL020547Sep 17, 1999RXNo5,612,367<disabled><disabled>
Astrazeneca
ACCOLATE
zafirlukast
TABLET;ORAL020547Sep 26, 1996RXYes5,612,367<disabled><disabled>
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Paragraph IV activity for: ACCOLATE

Drugname Dosage Strength RLD Submissiondate
zafirlukastTablets10 mg and 20 mgAccolate2/29/2008
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