NDA 21201, held by Chemisch Fbrk Krsslr. Polidocanol.
As of Nov 14, 2026, NDA 21201 (Asclera), held by Chemisch Fbrk Krsslr, was first approved by FDA on Mar 30, 2010, with 3 approved supplements and 0 published complete response letters.
Asclera (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 30, 2010 | Original applicationNew molecular entity · Standard review | Approved |
| Asclera10MG/2ML (5MG/ML) · solution;intravenous | Polidocanol | RxReference drug |
| Asclera20MG/2ML (10MG/ML) · solution;intravenous | Polidocanol | RxReference drug |
| Jan 30, 2025 | Supplement 5Manufacturing | Approved | |
| Aug 29, 2019 | Supplement 4Labeling · Standard review | Approved | |
| Mar 1, 2018 | Supplement 2Labeling · Standard review | Approved | |
| Mar 30, 2010 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
