Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020248
Company: FRESENIUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INTRALIPID 20% SOYBEAN OIL 20% INJECTABLE;INJECTION Prescription AP 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
08/07/1996 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/25/2018 SUPPL-22 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-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020248s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017643Orig1s076,018449Orig1s043,019942Orig1s014,020248Orig1s020ltr.pdf
05/03/2010 SUPPL-16 Labeling

Label is not available on this site.

05/13/2005 SUPPL-13 Labeling

Label is not available on this site.

08/23/2001 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/23/2001 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/23/2001 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

10/10/2000 SUPPL-4 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

08/01/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/01/2016 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020248s020lbl.pdf

INTRALIPID 20%

INJECTABLE;INJECTION; 20%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INTRALIPID 20% SOYBEAN OIL 20% INJECTABLE;INJECTION Prescription Yes AP 018449 FRESENIUS
INTRALIPID 20% SOYBEAN OIL 20% INJECTABLE;INJECTION Prescription Yes AP 020248 FRESENIUS
NUTRILIPID 20% SOYBEAN OIL 20% INJECTABLE;INJECTION Prescription Yes AP 019531 B BRAUN

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