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LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PERRIGO R AND D · Approved 2018-09-05

Drug application

FDA Application #

ANDA209837

Application type

Abbreviated New Drug Application (Generic)

Brand name

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Generic name

LOPERAMIDE HYDROCHLORIDE, SIMETHICONE

Active ingredients

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Dosage form

TABLET

Route

ORAL

Marketing status

Over-the-counter

Sponsor

PERRIGO R AND D

Manufacturer

Rite Aid Corporation

First approval

2018-09-05

Source

Authoritative

Drugs@FDA application overview

Machine

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