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FDA ANDA · ANDA214541

ANTI-DIARRHEAL/ANTI-GAS MULTI-SYMPTOM RELIEF

loperamide hydrochloride 2mg, simethicone 125mg

Sponsor: GUARDIAN DRUG

APPLICATION
ANDA214541
TYPE
ANDA
ORIGINAL APPROVAL
2021-05-27
LATEST ACTION
2021-05-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONEOver-the-counter
LOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MG · TABLET · ORAL

Approval history

2021-05-27UNKNOWN · Original · standardAP
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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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