`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug
`Products
`
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`New Drug Application (NDA): 021779
`Company: ACTELION PHARMS LTD
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=021779)
`
`Products on NDA 021779
`
`CSVExcelPrint
`Drug
`Active
`Name
`Ingredients
`
`VENTAVIS
`
`ILOPROST
`
`VENTAVIS
`
`ILOPROST
`
`VENTAVIS
`
`ILOPROST
`
`Showing 1 to 3 of 3 entries
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`Strength
`
`Dosage Form/Route
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`20MCG/2ML
`(10MCG/ML)
`
`10MCG/ML
`(10MCG/ML)
`
`20MCG/ML
`(20MCG/ML)
`
`SOLUTION;INHALATION
`
`Discontinued
`
`No
`
`None
`
`SOLUTION;INHALATION
`
`Prescription
`
`Yes
`
`None
`
`SOLUTION;INHALATION
`
`Prescription
`
`Yes
`
`None
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 021779
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1099, p. 1 of 3
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`5/17/2017
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`Drugs@FDA: FDA Approved Drug Products
`
`Original Approvals or Tentative Approvals
`CSVExcelPrint
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`Review
`Priority;
`Orphan
`Status
`
`Letters, Reviews, Labels, Patient Package Insert
`
`12/29/2004 ORIG1
`
`Approval
`
`Type 1 New
`Molecular Entity
`
`PRIORITY
`;
`Orphan
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021779lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021779ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21779_Ventavis.cfm)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`CSVExcelPrint
`Action
`Date
`
`Submission
`
`01/05/2015 SUPPL16
`
`Submission
`Classification
`
`Manufacturing
`(CMC)
`
`11/10/2014
`
`SUPPL15
`
`Manufacturing
`(CMC)
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`11/25/2013
`
`SUPPL14
`
`04/26/2012 SUPPL13
`
`Labeling
`Package Insert
`
`Labeling
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021779s014lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021779Orig1s014ltr_corrected.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021779s013lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021779Orig1s013ltr.pdf)
`
`02/08/2011
`
`SUPPL12
`
`Labeling
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021779s012lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021779s012ltr.pdf)
`
`04/20/2010 SUPPL10
`
`Labeling
`Container/Carton
`Labels
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021779s010lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021779s010ltr.pdf)
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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
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`Action
`Date
`
`Submission
`
`08/07/2009 SUPPL9
`
`Submission
`Classification
`
`Labeling
`Package Insert,
`Labeling
`Container/Carton
`Labels
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021779s009lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021779s009ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021779Orig1s009.pdf)
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`09/22/2008 SUPPL8
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021779s008lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021779s008ltr.pdf)
`
`03/04/2008 SUPPL6
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021779s006lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021779s006ltr.pdf)
`
`12/08/2005 SUPPL3
`
`Manufacturing
`(CMC)Control
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s003lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021779s003ltr.pdf)
`
`08/24/2005 SUPPL2
`
`08/24/2005 SUPPL1
`
`Manufacturing
`(CMC)
`Formulation
`
`EfficacyNew
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s001,002lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021779s001,002ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s001,002lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021779s001,002ltr.pdf)
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`Showing 1 to 12 of 12 entries
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`Labels for NDA 021779
`
`
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`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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