Application 210589
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OMEGAVEN | FISH OIL TRIGLYCERIDES | EMULSION;INTRAVENOUS | 5GM/50ML (0.1GM/ML) | Yes | Yes |
| 002 | OMEGAVEN | FISH OIL TRIGLYCERIDES | EMULSION;INTRAVENOUS | 10GM/100ML (0.1GM/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-205 | Omegaven | Fish oil | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-205 | Omegaven | Fish oil | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-205 | Omegaven | Fish oil | Fresenius Kabi USA, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82945 | SUPPL | 2025-07-28 |
| 82930 | SUPPL | 2025-07-25 |
| 74295 | SUPPL | 2023-05-18 |
| 74278 | SUPPL | 2023-05-18 |
| 62932 | SUPPL | 2020-05-12 |
| 62899 | SUPPL | 2020-05-11 |
| 55294 | ORIG | 2018-08-24 |
| 55049 | ORIG | 2018-07-30 |
| 55034 | ORIG | 2018-07-27 |