Application 020248
- Type
- NDA
- Sponsor
- FRESENIUS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INTRALIPID 20% | SOYBEAN OIL | INJECTABLE;INJECTION | 20% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-0519 | Intralipid | SOYBEAN OIL | Baxter Healthcare CORP | NDA | Current |
| 0338-0519 | Intralipid | I.V. Fat Emulsion | Baxter Healthcare Corporation | NDA | Current |
| 0338-0519 | Intralipid | I.V. Fat Emulsion | Baxter Healthcare Corporation | NDA | Current |
| 0338-0519 | Intralipid | I.V. Fat Emulsion | Baxter Healthcare Corporation | NDA | Current |
| 0338-0519 | Intralipid | SOYBEAN OIL | Baxter Healthcare Corpora | NDA | Current |