← FDA DRUG APPROVALS

FDA NDA · NDA205098

VARITHENA

polidocanol

Sponsor: BOSTON SCITFC

APPLICATION
NDA205098
TYPE
NDA
ORIGINAL APPROVAL
2013-11-25
LATEST ACTION
2025-09-23
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

VARITHENA · ReferencePrescription
POLIDOCANOL 180MG/18ML (10MG/ML) · SOLUTION · INTRAVENOUS
VARITHENA · ReferenceDiscontinued
POLIDOCANOL 77.5MG/7.75ML (10MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-09-23Manufacturing (CMC) · Supplement 51 — Label ↗AP
2019-08-21Labeling · Supplement 31 · standard — Letter ↗AP
2017-12-21Labeling · Supplement 26 · standard — Label ↗AP
2016-06-23Labeling · Supplement 18 · standard — Label ↗AP
2016-06-17Manufacturing (CMC) · Supplement 17 · standardAP
2016-04-18Manufacturing (CMC) · Supplement 16 · standardAP
2016-03-04Manufacturing (CMC) · Supplement 13 · standardAP
2016-01-21Manufacturing (CMC) · Supplement 14 · standardAP
2015-11-20Manufacturing (CMC) · Supplement 12 · standardAP
2015-08-06Manufacturing (CMC) · Supplement 10 · standardAP
2015-06-02Manufacturing (CMC) · Supplement 8 · standardAP
2015-05-11Manufacturing (CMC) · Supplement 9 · standardAP
2015-04-23Manufacturing (CMC) · Supplement 7 · standardAP
2015-01-20Manufacturing (CMC) · Supplement 6 · standardAP
2015-01-08Labeling · Supplement 5 · standard — Label ↗AP
2014-12-11Manufacturing (CMC) · Supplement 4 · standardAP
2014-09-16Manufacturing (CMC) · Supplement 2 · standardAP
2014-06-26Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2013-11-25Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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