LEVOFLOXACIN | A090343 | INFORLIFE SA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizens Petition from Baxter Healthcare Corporation FDA-2016-P-1547 · 5 docket documents Baxter Healthcare Corporation filed this Section 505(j) citizen petition requesting that the FDA amend the Orange Book to designate Levofloxacin in Dextrose 5% in Plastic Container (ANDA A090343, held by ACS Dobfar) as a second reference listed drug for Levofloxacin injection in 5% dextrose, replaci | Other | 2016-06-14 | Granted | Baxter Healthcare Corporation |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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