CYCLOPHOSPHAMIDE | N203856 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Kleinfeld, Kaplan and Becker FDA-1995-P-0359 · 5 docket documents Law offices Kleinfeld, Kaplan and Becker filed this petition on behalf of an unnamed company seeking ANDA approval for oral dosage forms of cyclophosphamide and etoposide under 21 U.S.C. §355(j). The petitioner requests that the FDA issue guidance specifying that human bioavailability or bioequivale | Other | 2017-04-04 | Granted | Kleinfeld, Kaplan and Becker |
Foley & Lardner LLP - Citizen Petition FDA-2013-P-0241 · 4 docket documents Foley & Lardner LLP filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that FDA determine that Cytoxan (cyclophosphamide) for Injection lyophilized formulation, originally approved under NDA 12-142, was not withdrawn from sale for reasons re | 505(q) | 2013-03-08 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.63
per ea
Lowest NADAC/Unit
$1.12
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00054038325CYCLOPHOSPHAMIDE 50 MG CAPSULE | $1.63 | EA | Generic | — | 2026-06-17 |
| 00054038225CYCLOPHOSPHAMIDE 25 MG CAPSULE | $1.12 | EA | Generic | — | 2026-02-18 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.