THIOTEPA | A075698 | FRESENIUS KABI USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from eVenus Pharmaceutical Laboratories Inc. FDA-2015-P-1503 eVenus Pharmaceutical Laboratories Inc. filed this citizen petition under 21 CFR §10.20 and §10.30 requesting that the FDA Commissioner designate a reference listed drug for Thiotepa Injection 15mg/vial in the Orange Book and Drugs@FDA to enable future sponsors to submit abbreviated new drug applica | Other | 2015-05-12 | Denied | eVenus Pharmaceutical Laboratories Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.