Drugs@FDA: FDA-Approved Drugs

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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.cfm 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
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
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