← FDA Drug Approvals (Drugs@FDA)
OBETICHOLIC ACID
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: OPTIMUS PHARMA PRIVATE LTD · Approved 2023-07-20
Drug application
- FDA Application #
ANDA214935- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- OBETICHOLIC ACID
- Generic name
- Obeticholic Acid
- Active ingredients
- OBETICHOLIC ACID
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- OPTIMUS PHARMA PRIVATE LTD
- First approval
- 2023-07-20
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown