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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020471

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ZYFLO (ZILEUTON)
600MG
Marketing Status: Prescription
Active Ingredient: ZILEUTON
Proprietary Name: ZYFLO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 600MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020471
Product Number: 003
Approval Date: Dec 9, 1996
Applicant Holder Full Name: CHIESI USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ZYFLO (ZILEUTON)
300MG
Marketing Status: Discontinued
Active Ingredient: ZILEUTON
Proprietary Name: ZYFLO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020471
Product Number: 001
Approval Date: Dec 9, 1996
Applicant Holder Full Name: CHIESI USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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