IRON SUCROSE | A208977 | INTERNATIONAL MEDICATION SYSTEMS LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Sidley Austin LLP on behalf of Vifor Pharma FDA-2020-P-0158 · 6 docket documents Sidley Austin LLP, on behalf of Vifor Pharma, filed this citizen petition in January 2020 requesting that the FDA clarify that the ANDA pathway under Section 505(j) is inappropriate for follow-on harder-to-copy complex drugs and that approvals for such drugs must instead proceed under Section 505(b) | 505(q) | 2020-01-10 | Open | Vifor Pharma |
Luitpold Pharmaceuticals, Inc., (Sonnenschein Nath & Rosenthal, LLP) - Citize... FDA-2005-P-0319 · 21 docket documents Luitpold Pharmaceuticals, Inc., filed this citizen petition on March 3, 2005, requesting that the FDA withhold approval of any Abbreviated New Drug Application (ANDA) or 505(b)(2) application for generic versions or pharmaceutical alternatives of VENOFER (iron sucrose injection, USP) unless applican | 505(q) | 2010-05-14 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| CGT | Feb 8, 2026 | Expired |