BLA 101995, held by Smith And Nephew. Collagenase.
As of Nov 14, 2026, BLA 101995 (Santyl), held by Smith And Nephew, was first approved by FDA on Jun 4, 1965, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Collagenase Santyl ◊ Ointment is indicated for debriding chronic dermal ulcers 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 and severely burned areas. 3, 4, 5, 7, 16, 19, 20, 21
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 4, 1965 | Original applicationNew molecular entity | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Santyl250U/GRAM · ointment;topical | Collagenase | Rx |
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
