# LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
> **ANDA211438** · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD V · Approved 2021-06-17
## Drug
- **FDA Application Number:** ANDA211438
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
- **Generic name:** LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
- **Active ingredients:** LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** HETERO LABS LTD V
- **Manufacturer:** Camber Consumer Care Inc
- **First approval:** 2021-06-17
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211438)
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