Tools / Drug approvals and letters / Drugs Dextrose; Sodium Chloride Sold as Dextrose 5% In Sodium Chloride 0.9% In Plastic Container, Dextrose 5% In Sodium Chloride 0.45% In Plastic Container, Dextrose 5% In Sodium Chloride 0.33% In Plastic Container, Dextrose 5% In Sodium Chloride 0.2% In Plastic Container, Dextrose 10% And Sodium Chloride 0.9% In Plastic Container and 17 more. Every FDA application for this active ingredient: 27 branded and 5 generic.
As of Nov 15, 2026, FDA lists 32 applications for Dextrose; Sodium Chloride (sold as Dextrose 5% In Sodium Chloride 0.9% In Plastic Container, Dextrose 5% In Sodium Chloride 0.45% In Plastic Container, Dextrose 5% In Sodium Chloride 0.33% In Plastic Container and others), first approved Dec 8, 1970, with 0 new uses approved and 0 published complete response letters.
First approved : Dec 8, 1970 Applications : 32 New uses approved : 0 Complete response letters : 0 Clinical Trials 136 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Hypernatremia Fluid Therapy in Childhood Diarrhoea Hypernatremia, Acute Watery Diarrhea · International Centre for Diarrhoeal Disease Research, Bangladesh Not applicable Enrolling by invitation Oct 21, 2026 A Phase III, Randomized, Double-blind, Multi-center Trial Comparing Efficacy and Safety of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer Myelosuppression · Jiangsu Simcere Pharmaceutical Co., Ltd. Phase 3 Active, not recruiting Oct 19, 2026 Effects of Pre-Run Nutritional Supplements During a Fixed-Pace 5 km Treadmill Run Exercise Physiology, Nutritional Supplementation · St. Louis University Not applicable Recruiting Oct 2, 2026 Hypothalamic GLP-1 Response in Healthy Weight and Obesity Obesity, Normal Weight · University of Copenhagen Not applicable Recruiting Oct 2, 2026 Effects of Pistachios on Postprandial Metabolic Responses in Adults With Overweight or Obesity Obesity / Overweight · St. Louis University Not applicable Recruiting Oct 2, 2026 Combined Stellate Ganglion Block With Median Nerve Hydrodissection Versus Median Nerve Hydrodissection Only in Carpal Tunnel Syndrome Carpal Tunnel Syndrome (CTS) · Fayoum University Not applicable Not yet recruiting Sep 24, 2026 Targeted Versus Standard Peri-operative Antibiotic Prophylaxis in Patients Colonized With Carbapenemase Producing Enterobacterales Undergoing Liver Transplantation Liver Transplant, Carbapenem-resistant Enterobacterales · IRCCS Azienda Ospedaliero-Universitaria di Bologna Phase 3 Not yet recruiting Aug 12, 2026 Ketosis, Immune Function and Metabolic Adaptation in Response to Short-term Fasting in Critical Illness Critical Illness, Fasting State · Karolinska University Hospital Not applicable Not yet recruiting Jul 31, 2026
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Dec 8, 1970 Dextrose 5% In Sodium Chloride 0.2% In Plastic Container NDA 16689 · New formulation or manufacturer 74 Marketed Dec 9, 1970 Dextrose 5% In Sodium Chloride 0.9% In Plastic Container NDA 16678 · New formulation or manufacturer 75 Marketed Mar 22, 1971 Dextrose 5% In Sodium Chloride 0.45% In Plastic Container NDA 16683 · New formulation or manufacturer 72 Marketed Mar 22, 1971 Dextrose 5% In Sodium Chloride 0.33% In Plastic Container NDA 16687 · New formulation or manufacturer 73 Marketed Mar 22, 1971 Dextrose 10% And Sodium Chloride 0.9% In Plastic Container NDA 16696 · New formulation or manufacturer 68 Discontinued Mar 22, 1971 Dextrose 2.5% And Sodium Chloride 0.45% In Plastic Container NDA 16697 · New formulation or manufacturer 70 Marketed Aug 13, 1975 Dextrose 5% And Sodium Chloride 0.225% In Plastic Container NDA 17606 · New formulation or manufacturer 102 Marketed Aug 13, 1975 Dextrose 5% And Sodium Chloride 0.45% In Plastic Container NDA 17607 · New formulation or manufacturer 104 Marketed Jan 7, 1976 Dextrose 5% And Sodium Chloride 0.9% In Plastic Container NDA 17585 · New formulation or manufacturer 104 Marketed Apr 12, 1977 Dextrose 5% And Sodium Chloride 0.3% In Plastic Container NDA 17799 · New formulation or manufacturer 95 Marketed Feb 8, 1978 Dextrose 5% And Sodium Chloride 0.9% In Plastic Container NDA 18026 18 Discontinued Feb 21, 1978 Dextrose 10% And Sodium Chloride 0.9% In Plastic Container NDA 18047 17 Discontinued Feb 24, 1978 Dextrose 2.5% And Sodium Chloride 0.45% In Plastic Container, Dextrose 5% And Sodium Chloride 0.45% In Plastic Container NDA 18030 · New formulation or manufacturer 19 Discontinued Jun 28, 1979 Dextrose 10% And Sodium Chloride 0.45% In Plastic Container NDA 18229 · New formulation or manufacturer 12 Discontinued Aug 17, 1979 Dextrose 2.5% And Sodium Chloride 0.45% In Plastic Container NDA 18096 · New formulation or manufacturer 64 Discontinued Jul 11, 1980 Dextrose 2.5% And Sodium Chloride 0.9% In Plastic Container NDA 18376 · New formulation or manufacturer 10 Discontinued Jul 11, 1980 Dextrose 10% And Sodium Chloride 0.2% In Plastic Container NDA 18386 · New formulation or manufacturer 11 Discontinued Feb 24, 1988 Dextrose 2.5% And Sodium Chloride 0.11% In Plastic Container, Dextrose 2.5% And Sodium Chloride 0.2% In Plastic Container NDA 19631 · New formulation or manufacturer 24 Marketed Dec 20, 2019 Dextrose 2.5% And Sodium Chloride 0.45% In Plastic Container ANDA 211190 0 Marketed Aug 26, 2020 Dextrose 5% And Sodium Chloride 0.3% In Plastic Container ANDA 211194 0 Marketed Sep 14, 2020 Dextrose 5% And Sodium Chloride 0.9% ANDA 211211 0 Marketed Sep 15, 2020 Dextrose 5% And Sodium Chloride 0.225% ANDA 211221 0 Marketed Sep 15, 2020 Dextrose 5% And Sodium Chloride 0.45% ANDA 211276 0 Marketed — Dextrose 3.3% And Sodium Chloride 0.3% In Plastic Container NDA 18055 0 Discontinued — Dextrose 5% And Sodium Chloride 0.2% In Plastic Container NDA 18399 0 Discontinued — Dextrose 5% And Sodium Chloride 0.45% In Plastic Container NDA 18400 0 Discontinued — Dextrose 5% And Sodium Chloride 0.9% In Plastic Container NDA 18500 0 Discontinued — Dextrose 5% And Sodium Chloride 0.3% In Plastic Container NDA 18501 0 Discontinued — Dextrose 5% And Sodium Chloride 0.225% In Plastic Container NDA 19482 1 Discontinued — Dextrose 5% And Sodium Chloride 0.9% In Plastic Container NDA 19483 0 Discontinued — Dextrose 5% And Sodium Chloride 0.45% In Plastic Container NDA 19484 0 Discontinued — Dextrose 5% And Sodium Chloride 0.3% In Plastic Container NDA 19486 0 Discontinued
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Baxter Hlthcare
Fresenius Kabi USA
Abbott