Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 021272

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REMODULIN	TREPROSTINIL	1MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	AP	Yes	Yes
REMODULIN	TREPROSTINIL	2.5MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	AP	Yes	Yes
REMODULIN	TREPROSTINIL	5MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	AP	Yes	Yes
REMODULIN	TREPROSTINIL	10MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	AP	Yes	Yes
REMODULIN	TREPROSTINIL	20MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	None	Yes	Yes
REMODULIN	TREPROSTINIL	0.1MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	None	Yes	Yes
REMODULIN	TREPROSTINIL	0.2MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	None	Yes	Yes
REMODULIN	TREPROSTINIL	0.4MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021272

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
03/07/2023	SUPPL-37	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021272Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021272Orig1s037ltr.pdf
07/30/2021	SUPPL-32	Manufacturing (CMC)-New Strength	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021272Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021272Orig1s032ltr.pdf
08/19/2020	SUPPL-30	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021272Orig1s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021272Orig1s030ltr.pdf
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/2013/021272s020lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltredt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021272Orig1s020.pdf
12/22/2014	SUPPL-19	Labeling-Package Insert, Labeling-Container/Carton Labels	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

Labels for NDA 021272

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	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

Therapeutic Equivalents for NDA 021272

REMODULIN

INJECTABLE;INTRAVENOUS, 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;INTRAVENOUS, SUBCUTANEOUS	Prescription	Yes	AP	021272	UNITED THERAP
TREPROSTINIL	TREPROSTINIL	1MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	211574	ALEMBIC GLOBAL
TREPROSTINIL	TREPROSTINIL	1MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	210214	DR REDDYS
TREPROSTINIL	TREPROSTINIL	1MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	209382	ENDO OPERATIONS
TREPROSTINIL	TREPROSTINIL	1MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	203649	SANDOZ
TREPROSTINIL	TREPROSTINIL	1MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	206648	TEVA PHARMS USA

INJECTABLE;INTRAVENOUS, 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;INTRAVENOUS, SUBCUTANEOUS	Prescription	Yes	AP	021272	UNITED THERAP
TREPROSTINIL	TREPROSTINIL	2.5MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	211574	ALEMBIC GLOBAL
TREPROSTINIL	TREPROSTINIL	2.5MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	210214	DR REDDYS
TREPROSTINIL	TREPROSTINIL	2.5MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	209382	ENDO OPERATIONS
TREPROSTINIL	TREPROSTINIL	2.5MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	203649	SANDOZ
TREPROSTINIL	TREPROSTINIL	2.5MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	206648	TEVA PHARMS USA

INJECTABLE;INTRAVENOUS, 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;INTRAVENOUS, SUBCUTANEOUS	Prescription	Yes	AP	021272	UNITED THERAP
TREPROSTINIL	TREPROSTINIL	5MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	211574	ALEMBIC GLOBAL
TREPROSTINIL	TREPROSTINIL	5MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	210214	DR REDDYS
TREPROSTINIL	TREPROSTINIL	5MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	209382	ENDO OPERATIONS
TREPROSTINIL	TREPROSTINIL	5MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	203649	SANDOZ
TREPROSTINIL	TREPROSTINIL	5MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	206648	TEVA PHARMS USA

INJECTABLE;INTRAVENOUS, 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;INTRAVENOUS, SUBCUTANEOUS	Prescription	Yes	AP	021272	UNITED THERAP
TREPROSTINIL	TREPROSTINIL	10MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	211574	ALEMBIC GLOBAL
TREPROSTINIL	TREPROSTINIL	10MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	210214	DR REDDYS
TREPROSTINIL	TREPROSTINIL	10MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	209382	ENDO OPERATIONS
TREPROSTINIL	TREPROSTINIL	10MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	203649	SANDOZ
TREPROSTINIL	TREPROSTINIL	10MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	206648	TEVA PHARMS USA