← FDA DRUG APPROVALS

FDA ANDA · ANDA213484

ANTI-DIARRHEAL/ANTI-GAS CAPLETS

loperamide hydrochloride 2mg, simethicone 125mg

Sponsor: BIONPHARMA

APPLICATION
ANDA213484
TYPE
ANDA
ORIGINAL APPROVAL
2021-09-10
LATEST ACTION
2021-09-10
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

2021-09-10UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →