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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022387
Company: UNITED THERAP

Usage Instructions

Products on NDA 022387

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TYVASO	TREPROSTINIL	0.6MG/ML	SOLUTION;INHALATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022387

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/2009	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022387LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022387s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022387s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/20/2022	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022387s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022387Orig1s020ltr.pdf
03/31/2021	SUPPL-17	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022387s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022387Orig1s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/022387Orig1s017.pdf
10/19/2017	SUPPL-15	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022387s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022387Orig1s015ltr.pdf
06/06/2016	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022387s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022387Orig1s014ltr.pdf
06/23/2015	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/01/2014	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/20/2014	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022387s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022387Orig1s009ltr.pdf
04/30/2013	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022387s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022387Orig1s008ltr.pdf
01/07/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/08/2011	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022387s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022387s004ltr.pdf

Labels for NDA 022387

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/20/2022	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022387s020lbl.pdf
03/31/2021	SUPPL-17	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022387s017lbl.pdf
10/19/2017	SUPPL-15	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022387s015lbl.pdf
06/06/2016	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022387s014lbl.pdf
05/20/2014	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022387s009lbl.pdf
04/30/2013	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022387s008lbl.pdf
02/08/2011	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022387s004lbl.pdf
07/30/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022387LBL.pdf

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