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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019942
Company: FRESENIUS

Products on NDA 019942

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INTRALIPID 30%	SOYBEAN OIL	30%	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019942

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/1993	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019942_ORIGINAL_APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/22/2024	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019942s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019942Orig1s022ltr.pdf
05/17/2023	SUPPL-21	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-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019942s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017643Orig1s082, 018449Orig1s049, 019942Orig1s020, 020248Orig1s026ltr.pdf
07/25/2018	SUPPL-16	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-14	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017643Orig1s076,018449Orig1s043,019942Orig1s014,020248Orig1s020ltr.pdf
04/16/2004	SUPPL-10	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-5	Manufacturing (CMC)		Label is not available on this site.
09/27/2000	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
07/21/1999	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
03/18/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/29/1997	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 019942

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/22/2024	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019942s022lbl.pdf
05/17/2023	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017643s083,018449s050s051,019942s021,020248s027s028lbl.pdf
05/03/2022	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019942s020lbl.pdf

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