Application 019942
- Type
- NDA
- Sponsor
- FRESENIUS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INTRALIPID 30% | SOYBEAN OIL | INJECTABLE;INJECTION | 30% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-0520 | Intralipid | SOYBEAN OIL | Baxter Healthcare Corpora | NDA | Current |
| 0338-0520 | Intralipid | I.V. Fat Emulsion | Baxter Healthcare Corporation | NDA | Current |
| 0338-0520 | Intralipid | I. V. Fat Emulsion | Baxter Healthcare Corporation | NDA | Current |
| 0338-0520 | Intralipid | SOYBEAN OIL | Baxter Healthcare CORP | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82950 | SUPPL | 2025-07-28 |
| 82926 | SUPPL | 2025-07-25 |
| 77611 | SUPPL | 2024-02-23 |
| 77606 | SUPPL | 2024-02-23 |
| 74308 | SUPPL | 2023-05-18 |
| 74284 | SUPPL | 2023-05-18 |
| 71013 | SUPPL | 2022-05-06 |
| 70989 | SUPPL | 2022-05-04 |
| 55005 | SUPPL | 2018-07-26 |
| 46061 | SUPPL | 2016-12-06 |
| 41103 | ORIG | 2008-02-19 |
| 1827 | SUPPL | 2004-04-20 |