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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216204

IBUPROFEN AND DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE CITRATE; IBUPROFEN)
38MG;200MG
Marketing Status: Over-the-counter
Active Ingredient: DIPHENHYDRAMINE CITRATE; IBUPROFEN
Proprietary Name: IBUPROFEN AND DIPHENHYDRAMINE CITRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 38MG;200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A216204
Product Number: 001
Approval Date: May 31, 2022
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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