Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017643
Company: FRESENIUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INTRALIPID 10% SOYBEAN OIL 10% 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
10/07/1975 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-78 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
05/31/2016 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

12/01/2016 SUPPL-76 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/2016/017643s076.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017643Orig1s076,018449Orig1s043,019942Orig1s014,020248Orig1s020ltr.pdf
04/21/2016 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

12/15/2014 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

04/24/2007 SUPPL-72 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-70 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-65 Manufacturing (CMC)

Label is not available on this site.

09/27/2000 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1999 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1999 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

04/29/1997 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/2000 SUPPL-60 Labeling

Label is not available on this site.

02/17/1995 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/1991 SUPPL-57 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/24/1993 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1994 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1990 SUPPL-54 Labeling

Label is not available on this site.

06/20/1990 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

04/10/1989 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

01/29/1985 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1985 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/1984 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/1984 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1988 SUPPL-45 Labeling

Label is not available on this site.

05/27/1983 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1983 SUPPL-42 Labeling

Label is not available on this site.

06/07/1983 SUPPL-40 Labeling

Label is not available on this site.

01/27/1982 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1981 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1981 SUPPL-36 Labeling

Label is not available on this site.

02/10/1984 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1980 SUPPL-31 Labeling

Label is not available on this site.

05/14/1980 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/15/1979 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1979 SUPPL-28 Labeling

Label is not available on this site.

12/14/1979 SUPPL-27 Labeling

Label is not available on this site.

10/15/1979 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1980 SUPPL-25 Labeling

Label is not available on this site.

12/14/1979 SUPPL-24 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/16/1979 SUPPL-23 Labeling

Label is not available on this site.

07/09/1979 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1979 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1979 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

01/02/1980 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1979 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1979 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/1979 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/1978 SUPPL-15 Labeling

Label is not available on this site.

04/25/1979 SUPPL-14 Labeling

Label is not available on this site.

04/25/1979 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/1977 SUPPL-11 Labeling

Label is not available on this site.

03/06/1978 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/1978 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1978 SUPPL-8 Labeling

Label is not available on this site.

09/06/1978 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/1978 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1978 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/28/1977 SUPPL-3 Labeling

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-78 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017643s078,018449s045,019942s016,020248s022lbl.pdf
12/01/2016 SUPPL-76 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/2016/017643s076.pdf
04/24/2007 SUPPL-72 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017643s072,018449s039lbl.pdf

INTRALIPID 10%

INJECTABLE;INJECTION; 10%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INTRALIPID 10% SOYBEAN OIL 10% INJECTABLE;INJECTION Prescription Yes AP 017643 FRESENIUS
NUTRILIPID 10% SOYBEAN OIL 10% INJECTABLE;INJECTION Prescription Yes AP 019531 B BRAUN

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