Not in the current Orange Book— This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.
ALCOHOL; DEXTROSE | N004589 | B BRAUN
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Celerity Pharmaceuticals LLC FDA-2021-P-0375 · 7 docket documents 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and 5% Dextrose Injection in plastic containers under NDA 004589, held by B. Braun Medical Inc., was voluntarily withdrawn from sale for safety or effectiveness reasons purs | Other | 2021-04-12 | DeniedUnverified summary | Celerity Pharmaceuticals LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.