IRON DEXTRAN | N017441 | ALLERGAN SALES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-6222 · 11 docket documents Law firm Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that the FDA require submission of a Prior Approval Supplement with bioequivalence testing when sponsors of carbohydrate-iron complex products such as ferric carboxymaltose, ferric derisomaltose, ferumoxytol, iron dextran | Other | 2025-11-17 | Open | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from Luitpold Pharmaceuticals, Inc. (Arent Fox) FDA-1997-P-0353 · 7 docket documents 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, Inc. (Arent Fox) |
Luitpold Pharmaceuticals, Inc. - Citizen Petition FDA-2008-P-0524 · 5 docket documents Luitpold Pharmaceuticals, Inc. filed this citizen petition on September 23, 2008, requesting that the FDA require any new drug application (NDA) for ferumoxytol for iron deficiency anemia to contain the same rigorous clinical trial data and safety labeling as other intravenous iron dextran products, | 505(q) | 2008-10-02 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$18.90
per ml
Lowest NADAC/Unit
$18.90
per ml
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00023608210INFED 100 MG/2 ML VIAL | $18.90 | ML | Brand | — | 2026-01-02 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.