Application 212279
- Type
- NDA
- Sponsor
- GISKIT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EXEM FOAM KIT | AIR POLYMER-TYPE A | FOAM;INTRAUTERINE | 10ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 73254-310 | ExEm Foam | Air Polymer-Type A Intrauterine Foam | GISKIT B.V. | NDA | Current |
| 73254-310 | ExEm Foam | Air Polymer-Type A Intrauterine Foam | GISKIT B.V. | NDA | Current |
| 73254-310 | ExEm Foam | Air Polymer-Type A Intrauterine Foam | GISKIT PHARMA B.V. | NDA | Current |
| 73254-310 | ExEm Foam | Air Polymer-Type A Intrauterine Foam | GISKIT PHARMA B.V. | NDA | Current |