FDA approval · Drugs@FDA
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINERceftriaxone sodium
NDA050796 ·
FDA approved the original new drug application for CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER on April 20, 2005, sponsored by B BRAUN. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA050796
- Sponsor
- B BRAUN
- Original approval
- Review
- standard review
- Submission class
- Type 5 - New Formulation or New Manufacturer
- Active ingredient
- ceftriaxone sodium
Browse every approval whose brand starts with C, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| ceftriaxone sodium EQ 1GM BASE/VIAL | INJECTABLE | INJECTION | Prescription |
| ceftriaxone sodium EQ 2GM BASE/VIAL | INJECTABLE | INJECTION | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 11 · Manufacturing (CMC) 1. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to B BRAUN
- June 13, 2011CEFTAZIDIME IN DEXTROSE CONTAINERNDA050823
- May 6, 2010CEFEPIME AND DEXTROSE IN DUPLEX CONTAINERNDA050821
- August 9, 2007CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINERNDA065430
- March 10, 2006CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINERNDA065214
- July 29, 2004CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINERNDA050792
- February 21, 2001CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINERNDA050780
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