SINCALIDE | N017697 | BRACCO DIAGNOSTICS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Bracco Diagnostics Inc FDA-2017-P-6805 Bracco Diagnostics Inc. submitted this citizen petition on December 8, 2017, requesting that the FDA determine that the discontinued two-ingredient formulation of KINEVAC for injection was withdrawn for safety and efficacy reasons and should not be used as a reference listed drug for any Abbreviated | 505(q) | 2017-12-12 | Open | Bracco Diagnostics Inc |
Citizen Petition from Greenberg Traurig LLP ( on behalf of Bracco Diagnostics... FDA-2017-P-6649 Greenberg Traurig LLP, on behalf of Bracco Diagnostics Inc., filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine the two-ingredient formulation of KINEVAC for injection was discontinued for safety and efficacy reasons due to | 505(q) | 2017-11-29 | Withdrawn | Bracco Diagnostics Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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