← FDA Drug Approvals (Drugs@FDA)
RIVAROXABAN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: REGCON HOLDINGS · Approved 2025-08-11
Drug application
- FDA Application #
ANDA218445- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- RIVAROXABAN
- Generic name
- RIVAROXABAN
- Active ingredients
- RIVAROXABAN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- REGCON HOLDINGS
- Manufacturer
- Florida Pharmaceutical Products, LLC
- First approval
- 2025-08-11
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown