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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019487

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IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE)
1MG/5ML
Marketing Status: Over-the-counter
Active Ingredient: LOPERAMIDE HYDROCHLORIDE
Proprietary Name: IMODIUM A-D
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 1MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N019487
Product Number: 001
Approval Date: Mar 1, 1988
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE)
1MG/7.5ML
Marketing Status: Over-the-counter
Active Ingredient: LOPERAMIDE HYDROCHLORIDE
Proprietary Name: IMODIUM A-D
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 1MG/7.5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N019487
Product Number: 002
Approval Date: Jul 8, 2004
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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