Application 018449
- 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 | 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 CORP | NDA | Current |
| 0338-0519 | Intralipid | SOYBEAN OIL | Baxter Healthcare CORP | NDA | Current |
| 51662-1333 | INTRALIPID | INTRALIPID | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1333 | INTRALIPID | INTRALIPID | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1333 | INTRALIPID | INTRALIPID | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82949 | SUPPL | 2025-07-28 |
| 82925 | SUPPL | 2025-07-25 |
| 74307 | SUPPL | 2023-05-18 |
| 74306 | SUPPL | 2023-05-18 |
| 74283 | SUPPL | 2023-05-18 |
| 74282 | SUPPL | 2023-05-18 |
| 71014 | SUPPL | 2022-05-06 |
| 70988 | SUPPL | 2022-05-04 |
| 55033 | SUPPL | 2018-07-27 |
| 55004 | SUPPL | 2018-07-26 |
| 46060 | SUPPL | 2016-12-06 |
| 46016 | SUPPL | 2016-12-05 |
| 15005 | SUPPL | 2007-05-01 |
| 11220 | SUPPL | 2007-04-25 |
| 15004 | SUPPL | 2004-04-20 |