General MedicationsORALStandard
URSODIOL
URSODIOL
Standard Dose
200MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview URSODIOL is listed in Drugs@FDA under application 205789 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient URSODIOL Form and strength CAPSULE;ORAL - 200MG Sponsor LGM PHARMA Submission history Latest submission status date: 2020-05-08 00:00:00.
Structured Monograph
Clinical summary
Approval overview URSODIOL is listed in Drugs@FDA under application 205789 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient URSODIOL Form and strength CAPSULE;ORAL - 200MG Sponsor LGM PHARMA Submission history Latest submission status date: 2020-05-08 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.