Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022260
Company: ACTELION
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 | No |
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 | 213913 | MYLAN |
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 | 213913 | MYLAN |
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 |