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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 200888

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN)
25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Marketing Status: Over-the-counter
Active Ingredient: DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Proprietary Name: IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A200888
Product Number: 001
Approval Date: Mar 5, 2012
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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