GEMCITABINE HYDROCHLORIDE | N200795 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
OncoTherapies Limited - Citizen Petition FDA-2010-P-0096 · 4 docket documents OncoTherapies Limited submitted this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Gemcitabine Hydrochloride Injection, 10 mg/mL, suitable for consideration in an abbreviated new drug application (ANDA), with the propose | Other | 2010-02-23 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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