# ORENITRAM
> **NDA203496** · New Drug Application · Sponsor: UNITED THERAP · Approved 2013-12-20
## Drug
- **FDA Application Number:** NDA203496
- **Application type:** New Drug Application
- **Brand name:** ORENITRAM
- **Generic name:** TREPROSTINIL
- **Active ingredients:** TREPROSTINIL DIOLAMINE
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** UNITED THERAP
- **Manufacturer:** United Therapeutics Corporation
- **First approval:** 2013-12-20
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203496)
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