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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090468

ZYFREL (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
325MG/15ML;7.5MG/15ML
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Proprietary Name: ZYFREL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 325MG/15ML;7.5MG/15ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A090468
Product Number: 001
Approval Date: Apr 14, 2016
Applicant Holder Full Name: CYPRESS PHARMACEUTICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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