`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug
`Products
`
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`New Drug Application (NDA): 021272
`Company: UNITED THERAP
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
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`
`Products on NDA 021272
`
`CSVExcelPrint
`
`Drug Name
`
`Active
`Ingredients
`
`Strength
`
`Dosage Form/Route
`
`REMODULIN
`
`TREPROSTINIL
`
`1MG/ML
`
`REMODULIN
`
`TREPROSTINIL
`
`2.5MG/ML
`
`REMODULIN
`
`TREPROSTINIL
`
`5MG/ML
`
`REMODULIN
`
`TREPROSTINIL
`
`10MG/ML
`
`Showing 1 to 4 of 4 entries
`
`INJECTABLE;IV (INFUSION),
`SUBCUTANEOUS
`
`INJECTABLE;IV (INFUSION),
`SUBCUTANEOUS
`
`INJECTABLE;IV (INFUSION),
`SUBCUTANEOUS
`
`INJECTABLE;IV (INFUSION),
`SUBCUTANEOUS
`
`
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`Prescription
`
`Yes
`
`None
`
`Prescription
`
`Yes
`
`None
`
`Prescription
`
`Yes
`
`None
`
`Prescription
`
`Yes
`
`None
`
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`Drugs@FDA: FDA Approved Drug Products
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 021272
`
`
`
`Original Approvals or Tentative Approvals
`CSVExcelPrint
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`Review
`Priority;
`Orphan
`Status
`
`Letters, Reviews, Labels, Patient Package Insert
`
`07/05/2001 ORIG1
`
`Approval
`
`Type 1 New
`Molecular Entity
`
`PRIORITY
`;
`Orphan
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21272lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21272ini.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21272_Remodulin.cfm)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`CSVExcelPrint
`Action
`Date
`
`Submission
`
`01/22/2016 SUPPL22
`
`12/22/2014 SUPPL19
`
`01/03/2014 SUPPL21
`
`Submission
`Classification
`
`Manufacturing
`(CMC)
`
`Labeling
`Package Insert,
`Labeling
`Container/Carton
`Labels
`
`Manufacturing
`(CMC)
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021272s019lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021272Orig1s019ltr.pdf)
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`Drugs@FDA: FDA Approved Drug Products
`
`Action
`Date
`
`Submission
`
`09/26/2013 SUPPL20
`
`Submission
`Classification
`
`Labeling
`Package Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbledt.pdf)
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltredt.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltr.pdf)
`Review (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021272Orig1s020.pdf)
`
`02/08/2011
`
`SUPPL15
`
`Labeling
`Package Insert
`
`01/08/2010 SUPPL11
`
`Labeling
`
`09/12/2008 SUPPL8
`
`Labeling
`
`02/04/2008 SUPPL9
`
`Labeling
`
`03/20/2006 SUPPL5
`
`Efficacy
`Accelerated
`Approval
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021272s015lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021272s015ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021272s011lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021272s011ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s008lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021272s008ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s009lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021272s009ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021272S005lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021272S005ltr.pdf)
`Review (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021272Orig1s005.pdf)
`
`01/20/2006 SUPPL3
`
`Labeling
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021272s003ltr.pdf)
`
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`Drugs@FDA: FDA Approved Drug Products
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`Action
`Date
`
`Submission
`
`Submission
`Classification
`
`11/24/2004
`
`SUPPL2
`
`EfficacyNew
`Route Of
`Administration
`
`Showing 1 to 11 of 11 entries
`
`Labels for NDA 021272
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Review (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021272Orig1s002.pdf)
`
`
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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