# ROPINIROLE HYDROCHLORIDE
> **ANDA217862** · Abbreviated New Drug Application (Generic) · Sponsor: ELITE LABS INC · Approved 2025-11-10
## Drug
- **FDA Application Number:** ANDA217862
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** ROPINIROLE HYDROCHLORIDE
- **Generic name:** ROPINIROLE
- **Active ingredients:** ROPINIROLE HYDROCHLORIDE
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ELITE LABS INC
- **Manufacturer:** Elite Laboratories, Inc.
- **First approval:** 2025-11-10
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217862)
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