# LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
> **ANDA213484** · Abbreviated New Drug Application (Generic) · Sponsor: BIONPHARMA · Approved 2021-09-10
## Drug
- **FDA Application Number:** ANDA213484
- **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:** BIONPHARMA
- **Manufacturer:** YYBA CORP
- **First approval:** 2021-09-10
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213484)
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