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and 5% Dextrose Injection in plastic containers under NDA 004589, held by B. Braun Medical Inc., was voluntarily withdrawn from sale for safety or effectiveness reasons purs | Other | 2021-04-12 | Denied | Celerity Pharmaceuticals LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.