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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019531
Company: B BRAUN

Products on NDA 019531

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NUTRILIPID 10%	SOYBEAN OIL	10%	INJECTABLE;INJECTION	Prescription	None	Yes	Yes
NUTRILIPID 20%	SOYBEAN OIL	20%	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019531

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/1993	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019531s013s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019531Orig1s013,s016ltr.pdf
05/17/2023	SUPPL-13	Manufacturing (CMC)-Manufacturing Process	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019531Orig1s013,s016ltr.pdf
07/14/2020	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019531s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019531Orig1s010ltr.pdf
12/02/2015	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/12/2014	SUPPL-2	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019531s002lbl.pdf

Labels for NDA 019531

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2023	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019531s013s016lbl.pdf
07/14/2020	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019531s010lbl.pdf
08/12/2014	SUPPL-2	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019531s002lbl.pdf

Therapeutic Equivalents for NDA 019531

NUTRILIPID 10%

There are no Therapeutic Equivalents.

NUTRILIPID 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

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