U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 207648
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SMOFLIPID 20% FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) EMULSION;INTRAVENOUS Prescription None Yes Yes
SMOFLIPID 20% FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) EMULSION;INTRAVENOUS Prescription None Yes Yes
SMOFLIPID 20% FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) EMULSION;INTRAVENOUS Prescription None Yes Yes
SMOFLIPID 20% FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) EMULSION;INTRAVENOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/13/2016 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207648lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207648Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207648Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/22/2022 SUPPL-5 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207648s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207648Orig1s005ltr.pdf
05/08/2020 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207648s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207648Orig1s003, 210589Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/22/2022 SUPPL-5 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207648s005lbl.pdf
05/08/2020 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207648s003lbl.pdf
07/13/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207648lbl.pdf
Back to Top