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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078778

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE)
325MG;37.5MG
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Proprietary Name: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;37.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078778
Product Number: 001
Approval Date: Apr 7, 2014
Applicant Holder Full Name: NOSTRUM LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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