Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208276
Company: UNITED THERAP
Company: UNITED THERAP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
REMODULIN | TREPROSTINIL | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Discontinued | None | No | No |
REMODULIN | TREPROSTINIL | 50MG/20ML (2.5MG/ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Discontinued | None | No | No |
REMODULIN | TREPROSTINIL | 100MG/20ML (5MG/ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Discontinued | None | No | No |
REMODULIN | TREPROSTINIL | 200MG/20ML (10MG/ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Discontinued | None | No | 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 |
---|---|---|---|---|---|---|---|
07/30/2018 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208276s000,021272s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208276Orig1s000,021272Oirg1s025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208276Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/30/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208276s000,021272s025lbl.pdf |