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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090372

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ZAFIRLUKAST (ZAFIRLUKAST)
10MG
Marketing Status: Prescription
Active Ingredient: ZAFIRLUKAST
Proprietary Name: ZAFIRLUKAST
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090372
Product Number: 001
Approval Date: Nov 18, 2010
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ZAFIRLUKAST (ZAFIRLUKAST)
20MG
Marketing Status: Prescription
Active Ingredient: ZAFIRLUKAST
Proprietary Name: ZAFIRLUKAST
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090372
Product Number: 002
Approval Date: Nov 18, 2010
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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