Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019942
Company: FRESENIUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INTRALIPID 30% SOYBEAN OIL 30% INJECTABLE;INJECTION 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
12/30/1993 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019942_ORIGINAL_APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/25/2018 SUPPL-16 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017643Orig1s078,018449Orig1s045,019942Orig1s016,020248Orig1s022Ltr.pdf
12/01/2016 SUPPL-14 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017643Orig1s076,018449Orig1s043,019942Orig1s014,020248Orig1s020ltr.pdf
04/16/2004 SUPPL-10 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17643scs070,18449scs037,19942scs010ltr.pdf
08/22/2001 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/27/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1999 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/29/1997 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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