Details for New Drug Application (NDA): 022260
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NDA 022260 describes VELETRI, which is a drug marketed by Actelion and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VELETRI profile page.
The generic ingredient in VELETRI is epoprostenol sodium. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the epoprostenol sodium profile page.
The generic ingredient in VELETRI is epoprostenol sodium. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the epoprostenol sodium profile page.
Summary for 022260
| Tradename: | VELETRI |
| Applicant: | Actelion |
| Ingredient: | epoprostenol sodium |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022260
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 022260
Suppliers and Packaging for NDA: 022260
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VELETRI | epoprostenol sodium | INJECTABLE;INJECTION | 022260 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-402 | 66215-402-01 | 1 VIAL in 1 CARTON (66215-402-01) > 10 mL in 1 VIAL |
| VELETRI | epoprostenol sodium | INJECTABLE;INJECTION | 022260 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-403 | 66215-403-01 | 1 VIAL in 1 CARTON (66215-403-01) > 10 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1.5MG BASE/VIAL | ||||
| Approval Date: | Jun 27, 2008 | TE: | AP2 | RLD: | Yes | ||||
| Patent: | See Plans and Pricing | Patent Expiration: | Mar 15, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | See Plans and Pricing | Patent Expiration: | Feb 2, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.5MG BASE/VIAL | ||||
| Approval Date: | Jun 28, 2012 | TE: | AP2 | RLD: | Yes | ||||
| Patent: | See Plans and Pricing | Patent Expiration: | Mar 15, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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