CYCLOPHOSPHAMIDE | A040745 | BAXTER HEALTHCARE CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Epic Pharma LLC FDA-2023-P-2655 Epic Pharma LLC filed this petition pursuant to Section 505(j)(2)(C) of the FD&C Act and 21 CFR 314.161 requesting that the FDA Commissioner determine whether CYTOXAN (cyclophosphamide for injection, USP) in the formulation of sterile dry powder without added excipient at 500 mg, 1 gm, and 2 gm vial | 505(q) | 2023-06-28 | Withdrawn | Epic Pharma LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.