Drugs@FDA: FDA-Approved Drugs
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 | Discontinued | None | Yes | No |
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. |
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09/16/2014 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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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 |