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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220100
Company: BIONPHARMA

Products on ANDA 220100

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220100

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/19/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

LOPERAMIDE HYDROCHLORIDE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SOLUTION;ORAL; 1MG/7.5ML

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
IMODIUM A-D	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION;ORAL	Over-the-counter	Yes	019487	KENVUE BRANDS
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION;ORAL	Over-the-counter	No	220100	BIONPHARMA
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION;ORAL	Over-the-counter	No	091292	PERRIGO R AND D

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