Application 215371
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | KABILYTE | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | INJECTABLE;INJECTION | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65219-389 | Multiple Electrolytes pH 7.4 | sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71687 | ORIG | 2022-08-01 |