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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021140

IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE; SIMETHICONE)
2MG;125MG
Marketing Status: Over-the-counter
Active Ingredient: LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
Proprietary Name: IMODIUM MULTI-SYMPTOM RELIEF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG;125MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021140
Product Number: 001
Approval Date: Nov 30, 2000
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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