DOXORUBICIN HYDROCHLORIDE | N050718 | BAXTER HEALTHCARE CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Greenblum & Bernstein, P.L.C. FDA-2014-P-0210 Greenblum & Bernstein, P.L.C. filed this petition on behalf of its client on February 11, 2014, under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA either withdraw the designation of ANDA #203263 for doxorubicin hydrochloride (liposomal) injection as the Referenc | 505(q) | 2014-03-04 | Withdrawn | Greenblum & Bernstein, P.L.C. |
PharmaForce, Inc. - Citizen Petition FDA-2012-P-0200 PharmaForce, Inc. filed this citizen petition on February 29, 2012, pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA declare Doxorubicin Hydrochloride Injection, 2 mg/mL (100 mg/50 mL) suitable for consideration in an abbreviated new drug applicat | Other | 2012-03-14 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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