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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210755

IBUPROFEN (IBUPROFEN)
40MG/ML
Marketing Status: Over-the-counter
Active Ingredient: IBUPROFEN
Proprietary Name: IBUPROFEN
Dosage Form; Route of Administration: SUSPENSION/DROPS; ORAL
Strength: 40MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A210755
Product Number: 001
Approval Date: Sep 26, 2018
Applicant Holder Full Name: GUARDIAN DRUG CO
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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