← FDA Drug Approvals (Drugs@FDA)
URSODIOL
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIBROW HLTHCARE · Approved 2019-10-30
Drug application
- FDA Application #
ANDA212452- 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
- HIBROW HLTHCARE
- First approval
- 2019-10-30
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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