Application 213445
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;149MG/100ML;900MG/100ML | No | No |
| 002 | POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;298MG/100ML;900MG/100ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65219-118 | Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-119 | Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 67044 | ORIG | 2021-04-13 |