MESALAMINE | N019919 | MEDA PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Alembic Labs LLC (USA) FDA-2022-P-0929 · 5 docket documents Alembic Labs LLC submitted this citizen petition on May 27, 2022, requesting that the FDA designate the generic mesalamine delayed-release tablets 800 mg marketed by Zydus Pharmaceuticals USA Inc. under ANDA A203286 as an alternate Reference Listed Drug because the original RLD, ASACOL HD (mesalamin | 505(q) | 2022-05-27 | Open | Alembic Labs LLC (USA) |
Citizen Petition from US WorldMeds, LLC FDA-2019-P-3192 · 56 docket documents US WorldMeds, LLC filed this citizen petition requesting that the FDA revoke or restrict the marketing authorizations for certain mesalamine products, including brands such as Asacol HD, Apriso, Pentasa, and Lialda, due to alleged impurity concerns and manufacturing issues, and to require additional | Other | 2019-12-27 | Open | US WorldMeds, LLC |
Salix Pharmaceuticals, Inc. - Citizen Petition FDA-2013-P-0470 · 3 docket documents Salix Pharmaceuticals, Inc. filed this citizen petition under sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act to request that the FDA amend its bioequivalence criteria for mesalamine extended-release capsules and apply stricter requirements to any abbreviated new drug applicat | 505(q) | 2013-05-02 | Denied | — |
Warner Chilcott Company, LLC- Citizen Petition FDA-2012-P-1087 · 3 docket documents Warner Chilcott Company, LLC submitted this citizen petition under sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA clarify and establish criteria for demonstrating bioequivalence for mesalamine delayed-release tablets and apply such criteria to any ANDA | 505(q) | 2012-10-26 | Partially Denied | — |
Warner Chilcott Company, LLC - Citizen Petition FDA-2011-P-0575 · 3 docket documents Warner Chilcott Company, LLC filed this citizen petition under sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA apply previously announced bioequivalence standards for delayed-release mesalamine to Par Pharmaceutical Companies' ANDA for mesalamine delayed-re | 505(q) | 2011-08-12 | Granted | — |
Warner Chilcott Company, LLC - Citizen Petition FDA-2010-P-0111 · 13 docket documents Warner Chilcott Company, LLC filed this section 505(q) citizen petition on February 22, 2010, requesting that the FDA issue a bioequivalence guidance for mesalamine delayed-release tablets and refrain from approving any abbreviated new drug applications referencing Asacol and Asacol HD unless propos | 505(q) | 2010-03-02 | Denied | — |
Shire Pharmaceuticals, Inc. - Citizen Petition FDA-2008-P-0507 · 9 docket documents Shire Pharmaceuticals, Inc. filed this citizen petition under sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA require all Abbreviated New Drug Applications and Section 505(b)(2) applications for generic or follow-on formulations of Pentasa (mesalamine) | 505(q) | 2008-10-27 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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