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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017694

IMODIUM (LOPERAMIDE HYDROCHLORIDE)
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: LOPERAMIDE HYDROCHLORIDE
Proprietary Name: IMODIUM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N017694
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV
Marketing Status:  Discontinued
Patent and Exclusivity Information
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