Application 020047
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXTROSE 50% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 50GM/100ML | Yes | Yes |
| 002 | DEXTROSE 60% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 60GM/100ML | No | No |
| 003 | DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 70GM/100ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-0719 | DEXTROSE | Dextrose monohydrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0719 | DEXTROSE | Dextrose monohydrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0719 | DEXTROSE | Dextrose monohydrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0719 | DEXTROSE | Dextrose monohydrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0719 | DEXTROSE | Dextrose monohydrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0719 | DEXTROSE | Dextrose monohydrate | Baxter Healthcare Corporation | NDA | Current |