STERILE WATER FOR INJECTION | N018233 | OTSUKA ICU MEDICAL LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Fresenius Kabi USA, LLC FDA-2019-P-0175 · 2 docket documents Fresenius Kabi USA, LLC filed this citizen petition on January 9, 2019, requesting that the FDA determine whether Sterile Water for Injection, USP in a 250 mL fill size is suitable for submission in an Abbreviated New Drug Application (ANDA), to be submitted as a Prior Approval Supplement to their e | Other | 2019-01-10 | Open | Fresenius Kabi USA, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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