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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203496
Company: UNITED THERAP

Summary Review

Products on NDA 203496

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORENITRAM	TREPROSTINIL DIOLAMINE	EQ 0.125MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
ORENITRAM	TREPROSTINIL DIOLAMINE	EQ 0.25MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
ORENITRAM	TREPROSTINIL DIOLAMINE	EQ 1MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes
ORENITRAM	TREPROSTINIL DIOLAMINE	EQ 2.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
ORENITRAM	TREPROSTINIL DIOLAMINE	EQ 5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203496

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2013	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203496Orig1s000lbl_edt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203496Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203496Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203496Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/2020	SUPPL-13		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203496Orig1s013lbl.pdf
10/18/2019	SUPPL-11	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203496s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203496Orig1s011ltr.pdf
06/07/2017	SUPPL-7	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203496s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203496Orig1s007ltr.pdf
01/24/2017	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203496s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203496Orig1s006ltr.pdf
01/28/2016	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203496s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203496Orig1s002ltr.pdf
10/06/2014	SUPPL-1	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203496s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203496Orig1s001ltr.pdf

Labels for NDA 203496

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/2020	SUPPL-13	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203496Orig1s013lbl.pdf
10/18/2019	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203496s011lbl.pdf
06/07/2017	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203496s007lbl.pdf
01/24/2017	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203496s006lbl.pdf
01/28/2016	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203496s002lbl.pdf
10/06/2014	SUPPL-1	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203496s001lbl.pdf
12/20/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203496Orig1s000lbl_edt.pdf

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