FOSCARNET SODIUM | N020068 | CLINIGEN HEALTHCARE LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Apotex Corp. FDA-1998-P-0979 Apotex Corp. filed this citizen petition under section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting approval to submit an Abbreviated New Drug Application for Foscarnet Sodium Injection 12 mg/mL, a pre-diluted formulation of the reference listed drug Foscavir (foscarnet sodium) | Other | 2017-04-18 | Granted | Apotex Corp. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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