URSODIOL | N019594 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Pharmobedient Consulting, LLC FDA-2025-P-0184 · 4 docket documents Pharmobedient Consulting, LLC filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether the Reference Listed Drug ACTIGALL (Ursodiol) Capsules, 150 mg, approved under NDA 019594 and held by Teva Branded Pharmaceutical Produ | 505(q) | 2025-01-16 | Granted | Pharmobedient Consulting, LLC |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2006-P-0399 · 8 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client pursuant to Section 505(j)(2)(C) requesting that the FDA declare Ursodiol Capsules USP in strengths of 100 mg, 200 mg, and 400 mg suitable for submission as an abbreviated new drug application, with Actigall Capsules 300 mg | Other | 2008-11-18 | Granted | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.4208
per ea
Lowest NADAC/Unit
$0.4208
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00591315901URSODIOL 300 MG CAPSULE | $0.4208 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.