IRON DEXTRAN | N017441 | ALLERGAN SALES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Luitpold Pharmaceuticals, Inc. (Arent Fox) FDA-1997-P-0353 Luitpold Pharmaceuticals, Inc. filed this citizen petition requesting that the FDA withdraw approval of the intramuscular indication for INFeD (iron dextran injection) marketed by Schein Pharmaceuticals, arguing that there is no substantial evidence supporting this route of administration and that i | 505(q) | 2010-08-17 | Denied | Luitpold Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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