Application 214275
- Type
- NDA
- Sponsor
- ACTELION
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | UPTRAVI | SELEXIPAG | TABLET;ORAL | 200MCG | No | No |
| 002 | UPTRAVI | SELEXIPAG | TABLET;ORAL | 400MCG | No | No |
| 003 | UPTRAVI | SELEXIPAG | TABLET;ORAL | 600MCG | No | No |
| 004 | UPTRAVI | SELEXIPAG | TABLET;ORAL | 800MCG | No | No |
| 005 | UPTRAVI | SELEXIPAG | TABLET;ORAL | 1000MCG | No | No |
| 006 | UPTRAVI | SELEXIPAG | TABLET;ORAL | 1200MCG | No | No |
| 007 | UPTRAVI | SELEXIPAG | TABLET;ORAL | 1400MCG | No | No |
| 008 | UPTRAVI | SELEXIPAG | TABLET;ORAL | 1600MCG | No | No |
| 009 | UPTRAVI | SELEXIPAG | INJECTABLE;INJECTION | 1800MCG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N214275-001 | UPTRAVI | SELEXIPAG | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N214275-001 | 7205302 | 2026-10-31 | U-1797 | Drug substance, Drug product | 2021-08-27 |
| N214275-001 | 7205302*PED | 2027-04-30 | Pediatric extension | ||
| N214275-001 | 9173881 | 2029-08-12 | U-1798 | 2021-08-27 | |
| N214275-001 | 9173881*PED | 2030-02-12 | Pediatric extension | ||
| N214275-001 | 9284280 | 2030-06-25 | U-1831 | 2021-08-27 | |
| N214275-001 | 8791122 | 2030-08-01 | Drug substance, Drug product | 2021-08-27 | |
| N214275-001 | 9284280*PED | 2030-12-25 | Pediatric extension | ||
| N214275-001 | 8791122*PED | 2031-02-01 | Pediatric extension |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66215-718 | UPTRAVI | Selexipag | Actelion Pharmaceuticals US, Inc. | NDA | Current |
| 66215-718 | UPTRAVI | Selexipag | Actelion Pharmaceuticals US, Inc. | NDA | Current |
| 66215-718 | UPTRAVI | Selexipag | Actelion Pharmaceuticals US, Inc. | NDA | Current |
| 66215-718 | UPTRAVI | Selexipag | Actelion Pharmaceuticals US, Inc. | NDA | Current |
| 82595-000 | UPTRAVI | SELEXIPAG | EUROFINS AMATSIGROUP SAS | NDA | Current |