Application 018316
- Type
- NDA
- Sponsor
- ICU MEDICAL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SORBITOL-MANNITOL IN PLASTIC CONTAINER | MANNITOL; SORBITOL | SOLUTION;IRRIGATION | 540MG/100ML;2.7GM/100ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-7981 | Sorbitol-Mannitol | SORBITOL and MANNITOL | Hospira, Inc. | NDA | Current |
| 0409-7981 | Sorbitol-Mannitol | SORBITOL and MANNITOL | Hospira, Inc. | NDA | Current |
| 0990-7981 | Sorbitol-Mannitol | SORBITOL and MANNITOL | ICU Medical Inc. | NDA | Current |
| 0990-7981 | Sorbitol-Mannitol | SORBITOL and MANNITOL | ICU Medical Inc. | NDA | Current |
| 0990-7981 | Sorbitol-Mannitol | SORBITOL and MANNITOL | ICU Medical Inc. | NDA | Current |
| 0990-7981 | Sorbitol-Mannitol | SORBITOL and MANNITOL | ICU Medical Inc. | NDA | Current |