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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202076

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE)
325MG;37.5MG
Marketing Status: Prescription
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: AB
Application Number: A202076
Product Number: 001
Approval Date: Mar 30, 2012
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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