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LOPERAMIDE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BIONPHARMA · Approved 2025-09-19

Drug application

FDA Application #

ANDA220100

Application type

Abbreviated New Drug Application (Generic)

Brand name

LOPERAMIDE HYDROCHLORIDE

Generic name

LOPERAMIDE HYDROCHLORIDE ORAL

Active ingredients

LOPERAMIDE HYDROCHLORIDE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Over-the-counter

Sponsor

BIONPHARMA

Manufacturer

Bionpharma Inc.

First approval

2025-09-19

Source

Authoritative

Drugs@FDA application overview

Machine

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