Drugs@FDA: FDA-Approved Drugs

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NUTRILIPID 10% SOYBEAN OIL 10% INJECTABLE;INJECTION Prescription AP Yes Yes
NUTRILIPID 20% SOYBEAN OIL 20% INJECTABLE;INJECTION Prescription AP Yes Yes

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
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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
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

NUTRILIPID 10%

INJECTABLE;INJECTION; 10%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INTRALIPID 10% SOYBEAN OIL 10% INJECTABLE;INJECTION Prescription Yes AP 017643 FRESENIUS
NUTRILIPID 10% SOYBEAN OIL 10% INJECTABLE;INJECTION Prescription Yes AP 019531 B BRAUN

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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