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LOPERAMIDE HYDROCHLORIDE

NDA · New Drug Application · Sponsor: BIONPHARMA · Approved 2005-08-04

Drug application

FDA Application #

NDA021855

Application type

New Drug Application

Brand name

LOPERAMIDE HYDROCHLORIDE

Generic name

LOPERAMIDE HYDROCHLORIDE

Active ingredients

LOPERAMIDE HYDROCHLORIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Over-the-counter

Sponsor

BIONPHARMA

Manufacturer

CHAIN DRUG MARKETING ASSOCIATION INC.

First approval

2005-08-04

Source

Authoritative

Drugs@FDA application overview

Machine

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