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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205098
Company: PROVENSIS

Summary Review

Products on NDA 205098

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	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205098

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

Labels for NDA 205098

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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