Application 019873
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE | INJECTABLE;INJECTION | 5GM/100ML;31MG/100ML;130MG/100ML;26MG/100ML;320MG/100ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0264-7730 | Isolyte P in Dextrose | Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, and Potassium Phosphate, Dibasic | B. Braun Medical Inc. | NDA | Current |
| 0264-7730 | Isolyte P in Dextrose | Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, and Potassium Phosphate, Dibasic | B. Braun Medical Inc. | NDA | Current |
| 0264-7730 | Isolyte P in Dextrose | Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, and Potassium Phosphate, Dibasic | B. Braun Medical Inc. | NDA | Current |