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FDA ANDA · ANDA076029

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Sponsor: PERRIGO

APPLICATION
ANDA076029
TYPE
ANDA
ORIGINAL APPROVAL
2002-08-30
LATEST ACTION
2021-07-09
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued

Products

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONEDiscontinued
LOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MG · TABLET, CHEWABLE · ORAL

Approval history

2021-07-09Labeling · Supplement 31 · standardAP
2009-04-30Labeling · Supplement 25AP
2007-11-06Labeling · Supplement 8AP
2007-06-29Manufacturing (CMC) · Supplement 14AP
2007-06-29Manufacturing (CMC) · Supplement 15AP
2002-08-30OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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