Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203496
Company: UNITED THERAP
Company: UNITED THERAP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ORENITRAM | TREPROSTINIL DIOLAMINE | EQ 0.125MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
ORENITRAM | TREPROSTINIL DIOLAMINE | EQ 0.25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
ORENITRAM | TREPROSTINIL DIOLAMINE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | Yes |
ORENITRAM | TREPROSTINIL DIOLAMINE | EQ 2.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
ORENITRAM | TREPROSTINIL DIOLAMINE | EQ 5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/20/2013 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203496Orig1s000lbl_edt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203496Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203496Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203496Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/03/2020 | SUPPL-13 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203496Orig1s013lbl.pdf | ||
10/18/2019 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203496s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203496Orig1s011ltr.pdf | |
06/07/2017 | SUPPL-7 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203496s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203496Orig1s007ltr.pdf | |
01/24/2017 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203496s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203496Orig1s006ltr.pdf | |
01/28/2016 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203496s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203496Orig1s002ltr.pdf | |
10/06/2014 | SUPPL-1 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203496s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203496Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/03/2020 | SUPPL-13 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203496Orig1s013lbl.pdf | |
10/18/2019 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203496s011lbl.pdf | |
06/07/2017 | SUPPL-7 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203496s007lbl.pdf | |
01/24/2017 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203496s006lbl.pdf | |
01/28/2016 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203496s002lbl.pdf | |
10/06/2014 | SUPPL-1 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203496s001lbl.pdf |
12/20/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203496Orig1s000lbl_edt.pdf |