NDA 50792, held by B Braun. Cefotaxime Sodium.
As of Nov 13, 2026, NDA 50792 (Cefotaxime And Dextrose 2.4% In Plastic Container, Cefotaxime And Dextrose 3.9% In Plastic Container), held by B Braun, was first approved by FDA on Jul 29, 2004, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 29, 2004 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cefotaxime And Dextrose 2.4% In Plastic ContainerEQ 2GM BASE · injectable;injection | Cefotaxime Sodium | Discontinued |
| Cefotaxime And Dextrose 3.9% In Plastic ContainerEQ 1GM BASE · injectable;injection | Cefotaxime Sodium | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 10, 2007 | Supplement 2Labeling · Standard review | Approved | |
| Jul 29, 2004 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
