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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 218311

ACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN; IBUPROFEN)
250MG;125MG
Marketing Status: Over-the-counter
Active Ingredient: ACETAMINOPHEN; IBUPROFEN
Proprietary Name: ACETAMINOPHEN AND IBUPROFEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG;125MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A218311
Product Number: 001
Approval Date: Apr 26, 2024
Applicant Holder Full Name: GLENMARK PHARMACEUTICALS LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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