FDA approval · Drugs@FDA
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERdextrose, sodium chloride
NDA016697 ·
FDA approved the original new drug application for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER on March 22, 1971, sponsored by BAXTER HLTHCARE. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA016697
- Sponsor
- BAXTER HLTHCARE
- Original approval
- Review
- standard review
- Submission class
- Type 5 - New Formulation or New Manufacturer
- Active ingredient
- dextrose, sodium chloride
Browse every approval whose brand starts with D, 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 |
|---|---|---|---|
| dextrose 2.5GM/100ML; sodium chloride 450MG/100ML | 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: Manufacturing (CMC) 58 · Labeling 12. 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 BAXTER HLTHCARE
- December 24, 2008NEXTERONENDA022325
- August 5, 2008CEFEPIME IN PLASTIC CONTAINERNDA050817
- March 21, 2002MESNEXNDA020855
- August 26, 1998PROSOL 20% SULFITE FREE IN PLASTIC CONTAINERNDA020849
- September 29, 1997CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINERNDA020734
- March 26, 1997CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINERNDA020678
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