Application 021338
- Type
- NDA
- Sponsor
- THE MEDICINES CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IONSYS | FENTANYL HYDROCHLORIDE | SYSTEM;IONTOPHORESIS, TRANSDERMAL | EQ 40MCG BASE/ACTIVATION | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65293-011 | IONSYS | fentanyl iontophoretic transdermal system | The Medicines Company | NDA | Current |