For minimal carbohydrate calories. NDA 19685, held by Otsuka Icu Medcl. Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate.
As of Nov 14, 2026, NDA 19685 (Potassium Chloride 5meq In Dextrose 5% And Lactated Ringer'S In Plastic Container, Potassium Chloride 20meq In Dextrose 5% And Lactated Ringer'S In Plastic Container, Potassium Chloride 30meq In Dextrose 5% And Lactated Ringer'S In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Oct 17, 1988, with 13 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE This solution is indicated in patients requiring parenteral administration of potassium chloride and the replacement of extracellular losses of fluids and electrolytes with minimal carbohydrate calories.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 17, 1988 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Potassium Chloride 5meq In Dextrose 5% And Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML · injectable;injection | Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate | DiscontinuedReference drug |
| Potassium Chloride 20meq In Dextrose 5% And Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML · injectable;injection | Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate | RxReference drug |
| Potassium Chloride 30meq In Dextrose 5% And Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML · injectable;injection | Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate | DiscontinuedReference drug |
| Potassium Chloride 40meq In Dextrose 5% And Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML · injectable;injection | Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate | DiscontinuedReference drug |
| Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML · injectable;injection | Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate | DiscontinuedReference drug |
| Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML · injectable;injection | Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate | DiscontinuedReference drug |
| Potassium Chloride 15meq In Dextrose 5% And Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML · injectable;injection | Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate | DiscontinuedReference drug |
| Potassium Chloride 20meq In Dextrose 5% And Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML · injectable;injection | Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate | DiscontinuedReference drug |
| Sep 8, 2014 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Aug 15, 2014 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jul 27, 2001 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| May 19, 1999 | Supplement 12Labeling | Approved | None posted |
| Aug 29, 1996 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Aug 14, 1995 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1988 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
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