Application 019626
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXTROSE 2.5% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 2.5GM/100ML | No | No |
| 002 | DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 5GM/100ML | Yes | Yes |
| 003 | DEXTROSE 7.7% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 7.7GM/100ML | No | No |
| 004 | DEXTROSE 10% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 10GM/100ML | Yes | Yes |
| 005 | 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 |
|---|---|---|---|---|---|
| 0264-7387 | Dextrose | Dextrose | B. Braun Medical Inc. | NDA | Current |
| 0264-7387 | Dextrose | Dextrose | B. Braun Medical Inc. | NDA | Current |
| 0264-7387 | Dextrose | Dextrose | B. Braun Medical Inc. | NDA | Current |
| 0264-7510 | DEXTROSE | DEXTROSE | B. Braun Medical Inc. | NDA | Current |
| 0264-7510 | DEXTROSE | DEXTROSE | B. Braun Medical Inc. | NDA | Current |
| 0264-7520 | DEXTROSE | DEXTROSE | B. Braun Medical Inc. | NDA | Current |
| 0264-7520 | DEXTROSE | DEXTROSE | B. Braun Medical Inc. | NDA | Current |