# LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
> **ANDA214541** · Abbreviated New Drug Application (Generic) · Sponsor: GUARDIAN DRUG · Approved 2021-05-27
## Drug
- **FDA Application Number:** ANDA214541
- **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:** GUARDIAN DRUG
- **Manufacturer:** Wal-Mart Stores, Inc.
- **First approval:** 2021-05-27
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214541)
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