Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208276
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

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