GEMCITABINE HYDROCHLORIDE | N208313 | SUN PHARMACEUTICAL INDUSTRIES LTD
| 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.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9241948 | Jul 1, 2033 | — | — | Yes | — | — |