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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021338-001 | IONSYS | FENTANYL HYDROCHLORIDE | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021338-001 | 8301238 | 2031-09-30 | Drug product | ||
| N021338-001 | 9364656 | 2031-09-30 | U-736 | 2016-06-21 | |
| N021338-001 | 9731121 | 2031-10-17 | Drug product | 2017-09-12 | |
| N021338-001 | 8781571 | 2032-03-31 | U-736 | Drug product | 2015-05-28 |
| N021338-001 | 8428708 | 2032-05-21 | U-736 | ||
| N021338-001 | 8428709 | 2032-06-11 | U-736 | Drug product | 2015-05-28 |
| N021338-001 | 9095706 | 2033-02-03 | Drug product | 2015-08-06 |
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 |