Application 211194
- 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 SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;300MG/100ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-867 | Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE and SODIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 64603 | ORIG | 2020-09-18 |