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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022260
Company: ACTELION

Summary Review

Products on NDA 022260

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VELETRI	EPOPROSTENOL SODIUM	EQ 1.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP2	Yes	Yes
VELETRI	EPOPROSTENOL SODIUM	EQ 0.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP2	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022260

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/2008	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Letter (PDF) Review Summary Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022260s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022260_epoprostenol_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022260s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/21/2020	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022260s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022260Orig1s012ltr.pdf
12/12/2018	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022260s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022260Orig1s010ltr.pdf
07/18/2016	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/03/2015	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/28/2012	SUPPL-5	Manufacturing (CMC)	Label (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022260s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022260Orig1s005.pdf
03/30/2011	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022260s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022260s004ltr.pdf
08/23/2010	SUPPL-2	Labeling-Proprietary Name Change	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022260s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022260s002ltr.pdf

Labels for NDA 022260

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/21/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022260s012lbl.pdf
12/12/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022260s010lbl.pdf
06/28/2012	SUPPL-5	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022260s005lbl.pdf
03/30/2011	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022260s004lbl.pdf
08/23/2010	SUPPL-2	Labeling-Proprietary Name Change	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022260s002lbl.pdf

Therapeutic Equivalents for NDA 022260

VELETRI

INJECTABLE;INJECTION; EQ 1.5MG BASE/VIAL
TE Code = AP2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPOPROSTENOL SODIUM	EPOPROSTENOL SODIUM	EQ 1.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP2	210473	SUN PHARM
VELETRI	EPOPROSTENOL SODIUM	EQ 1.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP2	022260	ACTELION

INJECTABLE;INJECTION; EQ 0.5MG BASE/VIAL
TE Code = AP2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPOPROSTENOL SODIUM	EPOPROSTENOL SODIUM	EQ 0.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP2	210473	SUN PHARM
VELETRI	EPOPROSTENOL SODIUM	EQ 0.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP2	022260	ACTELION

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