NDA 18069, held by Pfizer. Oxamniquine.
As of Nov 13, 2026, NDA 18069 (Vansil), held by Pfizer, was first approved by FDA on Jul 23, 1980, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 23, 1980 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vansil250MG · capsule;oral | Oxamniquine | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 24, 1992 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Jan 4, 1991 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Aug 6, 1984 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Jul 23, 1980 | Original applicationNew molecular entity · Priority review | Approved | None posted |
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
