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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211059

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (LOPERAMIDE HYDROCHLORIDE; SIMETHICONE)
2MG;125MG
Marketing Status: Over-the-counter
Active Ingredient: LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
Proprietary Name: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG;125MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A211059
Product Number: 001
Approval Date: Dec 14, 2020
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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