Application 212346
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% | DEXTROSE; POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;75MG/100ML | No | No |
| 002 | DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% | DEXTROSE; POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;150MG/100ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-667 | Potassium Chloride | Potassium Chloride, Dextrose Monohydrate | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-669 | Potassium Chloride | Potassium Chloride, Dextrose Monohydrate | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 65103 | ORIG | 2020-10-30 |