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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 074091

LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE)
2MG
Marketing Status: Over-the-counter
Active Ingredient: LOPERAMIDE HYDROCHLORIDE
Proprietary Name: LOPERAMIDE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A074091
Product Number: 001
Approval Date: Dec 10, 1992
Applicant Holder Full Name: OHM LABORATORIES INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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