FdaApplication
NDA 207648
Identifiers
- fda_app_no: NDA207648
Properties
| Property | Value |
|---|---|
| applicant_name | FRESENIUS KABI USA LLC |
| application_type | NDA |
| approval_date | 2016-07-13 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SMOFLIPID 20% | FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) | EMULSION;INTRAVENOUS |
| SMOFLIPID 20% | FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) | EMULSION;INTRAVENOUS |
| SMOFLIPID 20% | FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) | EMULSION;INTRAVENOUS |
| SMOFLIPID 20% | FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) | EMULSION;INTRAVENOUS |
4 products