URSODIOL | N020675 | ABBVIE INC
| 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.
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