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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209235

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE)
EQ 200MG FREE ACID AND POTASSIUM SALT;30MG
Marketing Status: Over-the-counter
Active Ingredient: IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 200MG FREE ACID AND POTASSIUM SALT;30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209235
Product Number: 001
Approval Date: Dec 1, 2017
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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