← FDA Drug Approvals (Drugs@FDA)
GUANFACINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: RUBICON RESEARCH · Approved 2025-04-15
Drug application
- FDA Application #
ANDA219689- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- GUANFACINE HYDROCHLORIDE
- Generic name
- GUANFACINE
- Active ingredients
- GUANFACINE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- RUBICON RESEARCH
- Manufacturer
- Advagen Pharma Limited
- First approval
- 2025-04-15
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown