← FDA Drug Approvals (Drugs@FDA)
URSODIOL
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLENMARK PHARMS LTD · Approved 2011-07-12
Drug application
- FDA Application #
ANDA090801- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- URSODIOL
- Generic name
- URSODIOL
- Active ingredients
- URSODIOL
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- GLENMARK PHARMS LTD
- Manufacturer
- BluePoint Laboratories
- First approval
- 2011-07-12
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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