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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204929

ZILEUTON (ZILEUTON)
600MG
Marketing Status: Prescription
Active Ingredient: ZILEUTON
Proprietary Name: ZILEUTON
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 600MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A204929
Product Number: 001
Approval Date: Mar 17, 2017
Applicant Holder Full Name: RISING PHARMA HOLDINGS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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