Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 210589
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMEGAVEN FISH OIL TRIGLYCERIDES 5GM/50ML (0.1GM/ML) EMULSION;INTRAVENOUS Prescription None Yes Yes
OMEGAVEN FISH OIL TRIGLYCERIDES 10GM/100ML (0.1GM/ML) 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
07/27/2018 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/0210589s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210589Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210589Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/27/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/0210589s000lbledt.pdf

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