CYCLOPHOSPHAMIDE | N012141 | BAXTER HEALTHCARE CORP
| 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that Cytoxan (cyclophosphamide) for Injection lyophilized formulation, originally approved under NDA 12-142, was not withdrawn from sale for reasons re | 505(q) | 2013-03-08 | Granted | — |
Steven A. Zecola - Citizen Petition FDA-2012-P-1160 · 4 docket documents Steven A. Zecola filed this citizen petition on November 15, 2012, requesting that the FDA withdraw approval of ACT chemotherapy (Adriamycin, Cytoxan, and Taxol) as adjuvant therapy for BRCA1-related breast cancer patients, arguing that clinical trial data supporting its use in triple-negative breas | Other | 2012-12-10 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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