Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022260
Company: ACTELION
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 Yes
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
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

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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