← FDA Drug Approvals (Drugs@FDA)
ROPINIROLE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PRINSTON INC · Approved 2022-05-11
Drug application
- FDA Application #
ANDA204413- 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
- PRINSTON INC
- Manufacturer
- Solco Healthcare US, LLC
- First approval
- 2022-05-11
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown