RIFAXIMIN | A208959 | ACTAVIS LABORATORIES FL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from BakerHostetler LLP (on behalf of Salix Pharmaceuticals ... FDA-2021-P-0096 · 30 docket documents Salix Pharmaceuticals, Inc., through counsel at BakerHostetler LLP, filed a citizen petition on December 28, 2020, requesting that the FDA refrain from approving any abbreviated new drug application under section 505(j) for generic versions of Xifaxan (rifaximin) unless approval incorporates specifi | 505(q) | 2021-02-03 | Partially Denied | Salix Pharmaceuticals Inc |
Salix Pharmaceuticals, Inc. - Citizen Petition FDA-2008-P-0300 · 4 docket documents Salix Pharmaceuticals, Inc., holder of NDA #21-361 for Xifaxan (rifaximin) Tablets, 200 mg, filed this citizen petition on May 14, 2008, requesting that the FDA refuse to receive or approve any ANDA referencing Xifaxan without scientifically appropriate bioequivalence data, including clinical endpoi | 505(q) | 2008-05-21 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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