NDA 21214, held by Sucampo Pharma LLC. Unoprostone Isopropyl.
As of Nov 14, 2026, NDA 21214 (Rescula), held by Sucampo Pharma LLC, was first approved by FDA on Aug 3, 2000, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 3, 2000 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rescula0.15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution/drops;ophthalmic | Unoprostone Isopropyl | DiscontinuedReference drug |
| Jul 10, 2014 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Dec 7, 2012 | Supplement 7Labeling · Standard review | Approved | |
| Dec 7, 2012 | Supplement 6Manufacturing · Priority review | Approved | |
| Dec 5, 2001 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Aug 3, 2000 | Original applicationNew molecular entity · Priority 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
