Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018449
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
01/23/1981 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-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017643s078,018449s045,019942s016,020248s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017643Orig1s078,018449Orig1s045,019942Orig1s016,020248Orig1s022Ltr.pdf
12/01/2016 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018449s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017643Orig1s076,018449Orig1s043,019942Orig1s014,020248Orig1s020ltr.pdf
04/24/2007 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017643s072,018449s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018449s039,017643s072ltr.pdf
04/16/2004 SUPPL-37 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-32 Manufacturing (CMC)

Label is not available on this site.

09/27/2000 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1999 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1999 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/29/1997 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/2000 SUPPL-27 Labeling

Label is not available on this site.

02/17/1995 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/1991 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/24/1993 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1994 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1990 SUPPL-20 Labeling

Label is not available on this site.

06/20/1990 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/10/1989 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/10/1985 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1985 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/1984 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/1984 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1988 SUPPL-13 Labeling

Label is not available on this site.

05/27/1983 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1983 SUPPL-10 Labeling

Label is not available on this site.

07/06/1982 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1983 SUPPL-8 Labeling

Label is not available on this site.

02/02/1982 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1981 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1981 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/06/1982 SUPPL-3 Labeling

Label is not available on this site.

04/03/1981 SUPPL-2 Labeling

Label is not available on this site.

02/15/1984 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/25/2018 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017643s078,018449s045,019942s016,020248s022lbl.pdf
12/01/2016 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018449s043lbl.pdf
04/24/2007 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017643s072,018449s039lbl.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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