FdaApplication
NDA 203496
Identifiers
- fda_app_no: NDA203496
Properties
| Property | Value |
|---|---|
| applicant_name | UNITED THERAPEUTICS CORP |
| application_type | NDA |
| approval_date | 2013-12-20 |
Revenue by product
ORENITRAM
| Period | Revenue |
|---|---|
| Q2 2026 | $125.7M |
| Q1 2026 | $135.6M |
| Q4 2025 | $121.2M |
| Q3 2025 | $131.1M |
| Q2 2025 | $123.9M |
| Q1 2025 | $120.7M |
| Q4 2024 | $107.8M |
| Q3 2024 | $113.2M |
| Q2 2024 | $107.1M |
| Q1 2024 | $106.2M |
| Q4 2023 | $84.1M |
| Q3 2023 | $92.0M |
| Q2 2023 | $95.1M |
| Q1 2023 | $88.2M |
| Q4 2022 | $75.8M |
| Q3 2022 | $87.5M |
Revenue as this company reported it for this product. A combination product's amount is stated once, for the product, and never divided across its ingredients. A fourth quarter is the reported full year less nine months, since no filing states one.
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ORENITRAM | TREPROSTINIL DIOLAMINE | EQ 2.5MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| ORENITRAM | TREPROSTINIL DIOLAMINE | EQ 0.125MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| ORENITRAM | TREPROSTINIL DIOLAMINE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| ORENITRAM | TREPROSTINIL DIOLAMINE | EQ 5MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| ORENITRAM | TREPROSTINIL DIOLAMINE | EQ 0.25MG BASE | TABLET, EXTENDED RELEASE;ORAL |
5 products