Application 018080
- Type
- NDA
- Sponsor
- ICU MEDICAL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXTROSE 10% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 10GM/100ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-7930 | Dextrose | dextrose monohydrate | Hospira, Inc. | NDA | Current |
| 0409-7930 | Dextrose | dextrose monohydrate | Hospira, Inc. | NDA | Current |
| 0409-7930 | Dextrose | dextrose monohydrate | Hospira, Inc. | NDA | Current |
| 0409-7938 | Dextrose | dextrose monohydrate | Hospira, Inc. | NDA | Current |
| 0409-7938 | Dextrose | dextrose monohydrate | Hospira, Inc. | NDA | Current |
| 0409-7938 | Dextrose | dextrose monohydrate | Hospira, Inc. | NDA | Current |
| 0990-7930 | Dextrose | dextrose monohydrate | ICU Medical Inc. | NDA | Current |
| 0990-7930 | Dextrose | dextrose monohydrate | ICU Medical Inc. | NDA | Current |
| 0990-7930 | Dextrose | dextrose monohydrate | ICU Medical Inc. | NDA | Current |
| 0990-7930 | Dextrose | dextrose monohydrate | ICU Medical Inc. | NDA | Current |
| 0990-7930 | Dextrose | dextrose monohydrate | ICU Medical Inc. | NDA | Current |
| 0990-7930 | Dextrose | dextrose monohydrate | ICU Medical Inc. | NDA | Current |
| 0990-7938 | Dextrose | dextrose monohydrate | ICU Medical Inc. | NDA | Current |
| 0990-7938 | Dextrose | dextrose monohydrate | ICU Medical Inc. | NDA | Current |
| 0990-7938 | Dextrose | dextrose monohydrate | ICU Medical Inc. | NDA | Current |
| 0990-7938 | Dextrose | dextrose monohydrate | ICU Medical Inc. | NDA | Current |