Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205098
Company: PROVENSIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VARITHENA POLIDOCANOL 180MG/18ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
VARITHENA POLIDOCANOL 77.5MG/7.75ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription None 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
11/25/2013 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205098s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205098Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205098Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205098Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/21/2019 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205098s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205098Orig1s031ltr.pdf
12/21/2017 SUPPL-26 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205098s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205098Orig1s026ltr.pdf
06/23/2016 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205098s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205098Orig1s018ltr.pdf
06/17/2016 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/18/2016 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/21/2016 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/04/2016 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/20/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/06/2015 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/11/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/02/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/23/2015 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/20/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/08/2015 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205098s005lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205098Orig1s005ltr.pdf
12/11/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/16/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/26/2014 SUPPL-1 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205098s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205098Origs001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/21/2019 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205098s031lbl.pdf
12/21/2017 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205098s026lbl.pdf
06/23/2016 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205098s018lbl.pdf
01/08/2015 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205098s005lbledt.pdf
06/26/2014 SUPPL-1 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205098s001lbl.pdf
11/25/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205098s000lbl.pdf

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