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): 204508
Company: BAXTER HLTHCARE CORP

Summary Review

Products on NDA 204508

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINOLIPID 20%	OLIVE OIL; SOYBEAN OIL	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204508

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/03/2013	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204508s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204508Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204508Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204508Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/24/2025	SUPPL-26	Labeling-Package Insert	Label (PDF) Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204508s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204508s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204508Orig1s026ltr.pdf
04/24/2024	SUPPL-22	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204508s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204508Orig1s022ltr.pdf
05/17/2023	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204508s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204508Orig1s019,s021ltr.pdf
05/17/2023	SUPPL-19	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204508s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204508Orig1s019,s021ltr.pdf
04/13/2021	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204508s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020678Orig1s042, 020734Orig1s037, 204508Orig1s015ltr.pdf
01/09/2017	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/20/2016	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204508s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204508Orig1s005ltr.pdf
02/08/2016	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/26/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/20/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
06/06/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 204508

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/24/2025	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204508s026lbl.pdf
07/24/2025	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204508s026lbl.pdf
04/24/2024	SUPPL-22	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204508s022lbl.pdf
05/17/2023	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204508s019s021lbl.pdf
05/17/2023	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204508s019s021lbl.pdf
05/17/2023	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204508s019s021lbl.pdf
04/13/2021	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204508s015lbl.pdf
07/20/2016	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204508s005lbl.pdf
10/03/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204508s000lbl.pdf

Top