Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/21/2002 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21272lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21272ini.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-272_Remodulin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/08/2018 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021272s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021272Orig1s026ltr.pdf
07/30/2018 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208276s000,021272s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208276Orig1s000,021272Oirg1s025ltr.pdf
01/22/2016 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/03/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/26/2013 SUPPL-20 Labeling-Package Insert Label (PDF)
Label (PDF)
Letter (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltredt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021272Orig1s020.pdf
12/22/2014 SUPPL-19 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021272s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021272Orig1s019ltr.pdf
02/08/2011 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021272s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021272s015ltr.pdf
01/08/2010 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021272s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021272s011ltr.pdf
02/04/2008 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021272s009ltr.pdf
09/12/2008 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021272s008ltr.pdf
03/20/2006 SUPPL-5 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021272S005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021272S005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021272Orig1s005.pdf
01/20/2006 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021272s003ltr.pdf
11/24/2004 SUPPL-2 Efficacy-New Route Of Administration Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021272Orig1s002.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021272s019lbl.pdf
12/22/2014 SUPPL-19 Labeling-Package Insert 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

REMODULIN

INJECTABLE;IV (INFUSION), SUBCUTANEOUS; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REMODULIN TREPROSTINIL 1MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription Yes AP 021272 UNITED THERAP
TREPROSTINIL TREPROSTINIL 1MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 203649 SANDOZ INC

INJECTABLE;IV (INFUSION), SUBCUTANEOUS; 2.5MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REMODULIN TREPROSTINIL 2.5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription Yes AP 021272 UNITED THERAP
TREPROSTINIL TREPROSTINIL 2.5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 203649 SANDOZ INC

INJECTABLE;IV (INFUSION), SUBCUTANEOUS; 5MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REMODULIN TREPROSTINIL 5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription Yes AP 021272 UNITED THERAP
TREPROSTINIL TREPROSTINIL 5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 203649 SANDOZ INC

INJECTABLE;IV (INFUSION), SUBCUTANEOUS; 10MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REMODULIN TREPROSTINIL 10MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription Yes AP 021272 UNITED THERAP
TREPROSTINIL TREPROSTINIL 10MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 203649 SANDOZ INC

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