CHOLINE C-11 | A205690 | UNIV TEXAS MD ANDERSON CANCER CENTER
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From University of TX MD Anderson Cancer Center FDA-2014-P-0513 · 3 docket documents The University of Texas MD Anderson Cancer Center filed this citizen petition under 21 CFR 314.93 requesting permission to file an Abbreviated New Drug Application for Choline C11 Injection with increased product concentration of 100 mCi/mL compared to the Reference Listed Drug NDA 203155 strength o | Other | 2014-05-02 | Granted | University of TX MD Anderson Cancer Center |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.