Application 019603
- Type
- NDA
- Sponsor
- ICU MEDICAL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MANNITOL 5% IN PLASTIC CONTAINER | MANNITOL | INJECTABLE;INJECTION | 5GM/100ML | No | No |
| 002 | MANNITOL 10% IN PLASTIC CONTAINER | MANNITOL | INJECTABLE;INJECTION | 10GM/100ML | No | No |
| 003 | MANNITOL 15% IN PLASTIC CONTAINER | MANNITOL | INJECTABLE;INJECTION | 15GM/100ML | No | No |
| 004 | MANNITOL 20% IN PLASTIC CONTAINER | MANNITOL | INJECTABLE;INJECTION | 20GM/100ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-7715 | Mannitol | MANNITOL | Hospira, Inc. | NDA | Current |
| 0409-7715 | Mannitol | MANNITOL | Hospira, Inc. | NDA | Current |
| 0990-7715 | Mannitol | MANNITOL | ICU Medical Inc. | NDA | Current |
| 0990-7715 | Mannitol | MANNITOL | ICU Medical Inc. | NDA | Current |
| 0990-7715 | Mannitol | MANNITOL | ICU Medical Inc. | NDA | Current |
| 0990-7715 | Mannitol | MANNITOL | ICU Medical Inc. | NDA | Current |