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Zafirlukast - Generic Drug Details

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Zafirlukast is the generic ingredient in two branded drugs marketed by Par Pharm Inc and Dr Reddys Labs Ltd, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for zafirlukast. Six suppliers are listed for this compound.

Summary for Generic Name: zafirlukast

Tradenames:2
Patents:0
Applicants:2
NDAs:2
Drug Master File Entries: see list2
Suppliers / Packaging: see list6
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: zafirlukast

Clinical Trials for: zafirlukast

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd
ZAFIRLUKAST
zafirlukast
TABLET;ORAL090372-002Nov 18, 2010RXNo<disabled><disabled>
Par Pharm Inc
ACCOLATE
zafirlukast
TABLET;ORAL020547-001Sep 26, 1996RXYes<disabled><disabled>
Dr Reddys Labs Ltd
ZAFIRLUKAST
zafirlukast
TABLET;ORAL090372-001Nov 18, 2010RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: zafirlukast

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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, 19965,612,367<disabled>
Par Pharm Inc
ACCOLATE
zafirlukast
TABLET;ORAL020547-003Sep 17, 19995,482,963<disabled>
Par Pharm Inc
ACCOLATE
zafirlukast
TABLET;ORAL020547-001Sep 26, 19965,583,152<disabled>
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