URSODIOL | A075517 | EPIC PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 42806050301URSODIOL 300 MG CAPSULE | $0.4208 | EA | Generic | — | 2026-06-17 |
| 00904622106URSODIOL 300 MG CAPSULE | $0.4208 | EA | Generic | — | 2026-06-17 |
| 00904622161URSODIOL 300 MG CAPSULE | $0.4208 | EA | Generic | — | 2026-06-17 |
| 24658078001URSODIOL 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.