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 |
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 |