← FDA Drug Approvals (Drugs@FDA)
URSODIOL
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LGM PHARMA · Approved 2020-05-08
Drug application
- FDA Application #
ANDA205789
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- URSODIOL
- Generic name
- URSODIOL
- Active ingredients
- URSODIOL
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- LGM PHARMA
- Manufacturer
- FH2 Pharma LLC
- First approval
- 2020-05-08
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown