For known or suspected infertility. NDA 212279, held by Giskit. Air Polymer-Type A.
As of Nov 14, 2026, NDA 212279 (Exem Foam Kit), held by Giskit, was first approved by FDA on Nov 7, 2019, with 0 approved supplements and 0 published complete response letters.
ExEm Foam is indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 7, 2019 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Exem Foam Kit10ML · foam;intrauterine | Air Polymer-Type A | RxReference drug |
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
