# LOPERAMIDE HYDROCHLORIDE
> **ANDA220153** · Abbreviated New Drug Application (Generic) · Sponsor: MARKSANS PHARMA · Approved 2025-11-17
## Drug
- **FDA Application Number:** ANDA220153
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** LOPERAMIDE HYDROCHLORIDE
- **Generic name:** LOPERAMIDE HYDROCHLORIDE TABLETS USP, 2MG
- **Active ingredients:** LOPERAMIDE HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** MARKSANS PHARMA
- **Manufacturer:** MARKSANS PHARMA LIMITED
- **First approval:** 2025-11-17
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220153)
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