Details for New Drug Application (NDA): 214275
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NDA 214275 describes UPTRAVI, which is a drug marketed by Actelion and is included in two NDAs. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the UPTRAVI profile page.
The generic ingredient in UPTRAVI is selexipag. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the selexipag profile page.
The generic ingredient in UPTRAVI is selexipag. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the selexipag profile page.
Pharmacology for NDA: 214275
| Mechanism of Action | Prostacyclin Receptor Agonists |
Suppliers and Packaging for NDA: 214275
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| UPTRAVI | selexipag | POWDER;INTRAVENOUS | 214275 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-718 | 66215-718-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (66215-718-01) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 1.8MG/VIAL | ||||
| Approval Date: | Jul 29, 2021 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 31, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING SELEXIPAG | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 1, 2030 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 12, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING SELEXIPAG IN COMBINATION WITH THE ENDOTHELIN RECEPTOR ANTAGONIST MACITENTAN | ||||||||
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