throbber
5/17/2017
`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug
`Products
`
` SHARE (HTTPS://WWW.FACEBOOK.COM/SHARER/SHARER.PHP?U=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=BASICSEARCH.PROCESS)
`
` TWEET (HTTPS://TWITTER.COM/INTENT/TWEET/?TEXT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=BASICSEARCH.PROCESS)
`
` 
`
`EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=BASICSEARCH.PROCESS)
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 022387 
`Company: UNITED THERAP
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=022387)
`
`Usage Instructions (http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022387UsageInstr.pdf)
`
`Products on NDA 022387
`
`CSVExcelPrint
`Drug
`Active
`Name
`Ingredients
`
`TREPROSTINIL
`TYVASO
`Showing 1 to 1 of 1 entries
`
`Strength
`
`Dosage Form/Route
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`0.6MG/ML
`
`SOLUTION;INHALATION
`
`Prescription
`
`Yes
`
`None
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 022387
`
`Original Approvals or Tentative Approvals
`CSVExcelPrint
`
`
`
`
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
`
`1/3
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1096, p. 1 of 3
`
`

`

`5/17/2017
`
`Drugs@FDA: FDA Approved Drug Products
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`07/30/2009 ORIG­1
`
`Approval
`
`Type 5 ­ New
`Formulation or
`New
`Manufacturer
`
`Review
`Priority;
`Orphan
`Status
`
`Letters, Reviews, Labels, Patient Package Insert
`
`STANDARD
`; 
`Orphan
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022387LBL.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022387s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022387s000TOC.cfm)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`CSVExcelPrint
`Action
`Date
`
`Submission
`
`06/06/2016 SUPPL­14
`
`Submission
`Classification
`
`Labeling­
`Package Insert
`
`06/23/2015 SUPPL­12
`
`Manufacturing
`(CMC)
`
`08/01/2014 SUPPL­11
`
`05/20/2014 SUPPL­9
`
`04/30/2013 SUPPL­8
`
`Labeling­
`Package Insert,
`Labeling­
`Container/Carton
`Labels, Labeling­
`Patient Package
`Insert
`
`Efficacy­Labeling
`Change With
`Clinical Data
`
`Labeling­
`Package Insert
`
`Letters, Reviews, Labels, 
`Patient Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022387s014lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022387Orig1s014ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022387s009lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022387Orig1s009ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022387s008lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022387Orig1s008ltr.pdf)
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
`
`2/3
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1096, p. 2 of 3
`
`

`

`5/17/2017
`
`Drugs@FDA: FDA Approved Drug Products
`
`Action
`Date
`
`Submission
`
`Submission
`Classification
`
`01/07/2013 SUPPL­7
`
`Manufacturing
`(CMC)
`
`Letters, Reviews, Labels, 
`Patient Package Insert
`
`02/08/2011
`
`SUPPL­4
`
`Labeling­
`Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022387s004lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022387s004ltr.pdf)
`
`Showing 1 to 7 of 7 entries
`
`Labels for NDA 022387
`
`
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
`
`3/3
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1096, p. 3 of 3
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket