Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
ALCOHOL; DEXTROSE | N004589 | B BRAUN
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Celerity Pharmaceuticals LLC FDA-2021-P-0375 Celerity Pharmaceuticals, LLC submitted this petition on April 12, 2021, requesting that the FDA determine whether 10% Alcohol and 5% Dextrose Injection in plastic containers under NDA 004589, held by B. Braun Medical Inc., was voluntarily withdrawn from sale for safety or effectiveness reasons purs | Other | 2021-04-12 | Denied | Celerity Pharmaceuticals LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.