`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug
`Products
`
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`New Drug Application (NDA): 022260
`Company: ACTELION PHARMS LTD
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
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`Products on NDA 022260
`
`CSVExcelPrint
`Drug
`Active
`Name
`Ingredients
`
`VELETRI
`
`EPOPROSTENOL
`SODIUM
`
`VELETRI
`
`EPOPROSTENOL
`SODIUM
`Showing 1 to 2 of 2 entries
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`Strength
`
`Dosage Form/Route
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`EQ 1.5MG
`BASE/VIAL
`
`EQ 0.5MG
`BASE/VIAL
`
`INJECTABLE;INJECTION
`
`Prescription
`
`Yes
`
`None
`
`INJECTABLE;INJECTION
`
`Prescription
`
`Yes
`
`None
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 022260
`
`Original Approvals or Tentative Approvals
`
`
`
`
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`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`Drugs@FDA: FDA Approved Drug Products
`
`Review
`Priority;
`Orphan
`Status
`
`Letters, Reviews, Labels, Patient Package Insert
`
`STANDARD Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022260s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022260_epoprostenol_toc.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022260s000_SumR.pdf)
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`CSVExcelPrint
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`06/27/2008 ORIG1
`
`Approval
`
`Type 5 New
`Formulation or
`New
`Manufacturer
`
`Showing 1 to 1 of 1 entries
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`Supplements
`CSVExcelPrint
`Action
`Date
`
`Submission
`
`07/18/2016 SUPPL8
`
`Submission
`Classification
`
`Manufacturing
`(CMC)
`
`03/03/2015 SUPPL7
`
`Manufacturing
`(CMC)
`
`06/28/2012 SUPPL5
`
`Manufacturing
`(CMC)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022260s005lbl.pdf)
`
`03/30/2011
`
`SUPPL4
`
`Labeling
`Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022260s004lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022260s004ltr.pdf)
`
`08/23/2010 SUPPL2
`
`Labeling
`Proprietary
`Name Change
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022260s002lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022260s002ltr.pdf)
`
`Showing 1 to 5 of 5 entries
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`Labels for NDA 022260
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`WATSON LABORATORIES, INC. , IPR2017-01621, Corrected Ex. 1098, p. 2 of 3
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`5/17/2017
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`Drugs@FDA: FDA Approved Drug Products
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`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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