An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020248
Company: FRESENIUS

Products on NDA 020248

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020248

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
05/17/2023	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017643s083,018449s050s051,019942s021,020248s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017643Orig1s083;018449Orig1s050,s051 019942Orig1s021;020248Orig1s027,s028ltr.pdf
05/17/2023	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017643s083,018449s050s051,019942s021,020248s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017643Orig1s083;018449Orig1s050,s051 019942Orig1s021;020248Orig1s027,s028ltr.pdf
05/03/2022	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020248s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017643Orig1s082, 018449Orig1s049, 019942Orig1s020, 020248Orig1s026ltr.pdf
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.

Labels for NDA 020248

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2023	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017643s083,018449s050s051,019942s021,020248s027s028lbl.pdf
05/17/2023	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017643s083,018449s050s051,019942s021,020248s027s028lbl.pdf
05/03/2022	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020248s026lbl.pdf
12/01/2016	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020248s020lbl.pdf

Therapeutic Equivalents for NDA 020248

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

Top