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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021272
Company: UNITED THERAP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REMODULIN TREPROSTINIL 1MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription AP Yes Yes
REMODULIN TREPROSTINIL 2.5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription AP Yes Yes
REMODULIN TREPROSTINIL 5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription AP Yes Yes
REMODULIN TREPROSTINIL 10MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription AP Yes Yes
REMODULIN TREPROSTINIL 20MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/30/2021 SUPPL-32 Manufacturing (CMC)-New Strength Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021272Orig1s032lbl.pdf
07/30/2021 SUPPL-32 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021272Orig1s032lbl.pdf
08/19/2020 SUPPL-30 Tentative Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021272Orig1s030lbl.pdf
07/30/2018 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208276s000,021272s025lbl.pdf
06/08/2018 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021272s026lbl.pdf
12/22/2014 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021272s019lbl.pdf
12/22/2014 SUPPL-19 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021272s019lbl.pdf
09/26/2013 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbl.pdf
09/26/2013 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbledt.pdf
02/08/2011 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021272s015lbl.pdf
01/08/2010 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021272s011lbl.pdf
09/12/2008 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s008lbl.pdf
02/04/2008 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s009lbl.pdf
03/20/2006 SUPPL-5 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021272S005lbl.pdf
05/21/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21272lbl.pdf
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