Active substance
Ursodiol
- US FDA 26
- Health Canada 8
- US price lines 3
- Safety 3
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ACTIGALL | 300MG | capsule · oral | TEVA BRANDED PHARM | Prescription | 31 Dec 1987 |
| URSODIOL | 300MG | capsule · oral | EPIC PHARMA | Prescription | 14 Mar 2000 |
| URSODIOL | 300MG | capsule · oral | LANNETT CO INC | Prescription | 15 Dec 2008 |
| URSODIOL | 250MG; 500MG | tablet · oral | GLENMARK PHARMS LTD | Prescription | 12 Jul 2011 |
| URSODIOL | 250MG; 500MG | tablet · oral | PH HEALTH | Prescription | 14 Feb 2013 |
| URSODIOL | 300MG | capsule · oral | ABHAI LLC | Prescription | 17 May 2018 |
| URSODIOL | 250MG; 500MG | tablet · oral | ZYDUS LIFESCIENCES | Prescription | 30 Oct 2018 |
| URSODIOL | 300MG | capsule · oral | ADAPTIS | Prescription | 30 Oct 2019 |
| URSODIOL | 300MG | capsule · oral | RISING | Prescription | 12 Feb 2020 |
| URSODIOL | 200MG; 400MG | capsule · oral | LGM PHARMA | Prescription | 8 May 2020 |
| URSODIOL | 300MG | capsule · oral | CHARTWELL RX | Prescription | 17 Aug 2020 |
| URSODIOL | 250MG; 500MG | tablet · oral | STRIDES PHARMA | Prescription | 20 Aug 2020 |
| URSODIOL | 300MG | capsule · oral | ZYDUS LIFESCIENCES | Prescription | 16 Oct 2020 |
| URSODIOL | 300MG; 150MG | capsule · oral | STRIDES PHARMA | Prescription | 22 Jan 2021 |
| URSODIOL | 300MG | capsule · oral | PHARMAZONE | Prescription | 28 Jul 2021 |
| URSODIOL | 300MG | capsule · oral | AUROBINDO PHARMA LTD | Prescription | 28 Nov 2022 |
| URSODIOL | 250MG; 500MG | tablet · oral | EPIC PHARMA LLC | Prescription | 14 Aug 2024 |
| ACTIGALL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | capsule · oral | TEVA BRANDED PHARM | Discontinued | 31 Dec 1987 |
| URSO 250 | 250MG | tablet · oral | ABBVIE | Discontinued | 10 Dec 1997 |
| URSO FORTE | 500MG | tablet · oral | ABBVIE | Discontinued | 10 Dec 1997 |
| URSODIOL | 300MG | capsule · oral | TEVA PHARMS | Discontinued | 25 May 2000 |
| URSODIOL | 300MG | capsule · oral | IMPAX LABS INC | Discontinued | 27 Jul 2006 |
| URSODIOL | 250MG; 500MG | tablet · oral | TEVA PHARMS USA | Discontinued | 13 May 2009 |
| URSODIOL | 300MG | capsule · oral | QUAGEN | Discontinued | 17 Feb 2010 |
| URSODIOL | 250MG; 500MG | tablet · oral | IMPAX LABS INC | Discontinued | 23 Dec 2011 |
1 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| GLN-URSODIOL | 02426900 | 250 MG | TABLET · ORAL | GLENMARK PHARMACEUTICALS CANADA INC. |
| GLN-URSODIOL | 02426919 | 500 MG | TABLET · ORAL | GLENMARK PHARMACEUTICALS CANADA INC. |
| JAMP-URSODIOL | 02472392 | 250 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-URSODIOL | 02472406 | 500 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| NRA-URSODIOL | 02544024 | 500 MG | TABLET · ORAL | NORA PHARMA INC |
| NRA-URSODIOL | 02544032 | 250 MG | TABLET · ORAL | NORA PHARMA INC |
| PMS-URSODIOL C | 02273497 | 250 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PMS-URSODIOL C | 02273500 | 500 MG | TABLET · ORAL | PHARMASCIENCE INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | URSODIOL 250 MG TABLET | $0.44954 | per EA | 23 Sep 2026 |
| US NADAC | URSODIOL 300 MG CAPSULE | $0.42919 | per EA | 23 Sep 2026 |
| US NADAC | URSODIOL 500 MG TABLET | $0.64709 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 19 Jul 2023 ACTIGALL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions - US FDA 12 Jan 2023 URSO 250 — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 12 Jan 2023 URSO FORTE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.