GEMCITABINE HYDROCHLORIDE | N020509 | ELI LILLY AND CO
| 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 | — |
PharmaForce - Citizen Petition FDA-2009-P-0076 · 2 docket documents This document is an Orange Book database search result showing application number 020509, which is the NDA for gemcitabine hydrochloride (Gemzar) manufactured by Lilly in injectable form at two strengths: 1 gram and 200 milligrams per vial. The document does not contain information about a citizen p | Other | 2009-02-20 | Open | — |
Olsson Frank Weeda Terman Bode Matz PC - Citizen Petition FDA-2008-P-0392 · 3 docket documents Olsson Frank Weeda Terman Bode Matz PC filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that FDA find Gemcitabine HCl Injection 38 mg/mL solution suitable for ANDA submission, representing a change in dosage form from the RLD Gemzar (lyophil | Other | 2008-07-14 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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