Application 019843
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | INJECTABLE;INJECTION | 5GM/100ML;30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0264-7704 | Isolyte S in Dextrose | Hydrous Dextrose, Sodium Chloride, Sodium Gluconate, Sodium Acetate Trihydrate, Potassium Chloride a | B. Braun Medical Inc. | ANDA | Current |