Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020547

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ACCOLATE (ZAFIRLUKAST)
10MG
Marketing Status: Prescription

Active Ingredient: ZAFIRLUKAST
Proprietary Name: ACCOLATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020547
Product Number: 003
Approval Date: Sep 17, 1999
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ACCOLATE (ZAFIRLUKAST)
20MG
Marketing Status: Prescription

Active Ingredient: ZAFIRLUKAST
Proprietary Name: ACCOLATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020547
Product Number: 001
Approval Date: Sep 26, 1996
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information