Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019627
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPRIVAN PROPOFOL 10MG/ML INJECTABLE;INJECTION Discontinued None No No
DIPRIVAN PROPOFOL 10MG/ML INJECTABLE;INJECTION Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/11/2021 SUPPL-72 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019627Orig1s072lbl.pdf
05/11/2021 SUPPL-72 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019627Orig1s072lbl.pdf
04/27/2017 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019627s066lbl.pdf
06/08/2014 SUPPL-62 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019627s062lbl.pdf
07/09/2013 SUPPL-60 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019627s60lbl.pdf
04/14/2008 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019627s046lbl.pdf
02/08/2007 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019627s045lbl.pdf
02/23/2001 SUPPL-35 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19627S35LBL.pdf

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