Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021855

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LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE)
1MG
Marketing Status: Over-the-counter

Active Ingredient: LOPERAMIDE HYDROCHLORIDE
Proprietary Name: LOPERAMIDE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021855
Product Number: 001
Approval Date: Aug 4, 2005
Applicant Holder Full Name: BIONPHARMA INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE)
2MG
Marketing Status: Over-the-counter

Active Ingredient: LOPERAMIDE HYDROCHLORIDE
Proprietary Name: LOPERAMIDE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021855
Product Number: 002
Approval Date: Aug 4, 2005
Applicant Holder Full Name: BIONPHARMA INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information