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LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GUARDIAN DRUG · Approved 2021-05-27

Drug application

FDA Application #

ANDA214541

Application type

Abbreviated New Drug Application (Generic)

Brand name

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Generic name

LOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MG

Active ingredients

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Dosage form

TABLET

Route

ORAL

Marketing status

Over-the-counter

Sponsor

GUARDIAN DRUG

Manufacturer

Wal-Mart Stores, Inc.

First approval

2021-05-27

Source

Authoritative

Drugs@FDA application overview

Machine

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