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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021272
Company: UNITED THERAP

Products on NDA 21272

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
REMODULIN	TREPROSTINIL	0.1MG/ML	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	Prescription	None	Yes	Yes
REMODULIN	TREPROSTINIL	0.2MG/ML	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	Prescription	None	Yes	Yes
REMODULIN	TREPROSTINIL	0.4MG/ML	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	Prescription	None	Yes	Yes

Labels for NDA 021272

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/07/2023	SUPPL-37	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021272Orig1s037lbl.pdf
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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