# LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
> **ANDA215981** · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2022-08-29
## Drug
- **FDA Application Number:** ANDA215981
- **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:** Discontinued
- **Sponsor:** GRANULES
- **Manufacturer:** Granules India Ltd
- **First approval:** 2022-08-29
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215981)
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