`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug
`Products
`
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`New Drug Application (NDA): 020444
`Company: GLAXOSMITHKLINE LLC
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=020444)
`
`Products on NDA 020444
`
`CSVExcelPrint
`Drug
`Active
`Name
`Ingredients
`
`FLOLAN
`
`EPOPROSTENOL
`SODIUM
`
`FLOLAN
`
`EPOPROSTENOL
`SODIUM
`Showing 1 to 2 of 2 entries
`
`Strength
`
`Dosage Form/Route
`
`Marketing
`Status
`
`EQ 0.5MG
`BASE/VIAL
`
`EQ 1.5MG
`BASE/VIAL
`
`INJECTABLE;INJECTION
`
`Prescription
`
`INJECTABLE;INJECTION
`
`Prescription
`
`TE
`Code
`
`AP
`
`AP
`
`RLD
`
`Yes
`
`Yes
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 020444
`
`Original Approvals or Tentative Approvals
`
`
`
`
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`Drugs@FDA: FDA Approved Drug Products
`
`CSVExcelPrint
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`Review
`Priority;
`Orphan
`Status
`
`Letters, Reviews,
`Labels, Patient
`Package Insert
`
`09/20/1995 ORIG1
`
`Approval
`
`Type 1 New
`Molecular Entity
`
`PRIORITY ;
`Orphan
`
`Notes
`
`Label is not
`available on
`this site.
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`CSVExcelPrint
`Action
`Date
`
`Submission
`
`Submission
`Classification
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`04/17/2015 SUPPL21
`
`Manufacturing
`(CMC)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020444s021lbl.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020444s018lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020444s018ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020444s016lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020444s016ltr.pdf)
`
`03/29/2011
`
`SUPPL18
`
`Labeling
`
`03/12/2008 SUPPL16
`
`Labeling
`
`09/20/2002 SUPPL10
`
`Manufacturing
`(CMC)
`
`06/21/2002 SUPPL9
`
`Manufacturing
`(CMC)
`
`06/21/2002 SUPPL8
`
`Manufacturing
`(CMC)
`Packaging
`
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`5/17/2017
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`Drugs@FDA: FDA Approved Drug Products
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Action
`Date
`
`Submission
`
`04/05/2002 SUPPL7
`
`Submission
`Classification
`
`Manufacturing
`(CMC)
`
`01/17/2002 SUPPL6
`
`Manufacturing
`(CMC)
`
`09/21/2000 SUPPL5
`
`Labeling
`
`04/14/2000 SUPPL3
`
`EfficacyNew
`Indication
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20444S03LBL.PDF)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20444S03LTR.PDF)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20
`444S003_Flolan.cfm)
`
`11/02/1999
`
`SUPPL4
`
`Labeling
`
`11/21/1997
`
`SUPPL2
`
`Manufacturing
`(CMC)
`
`03/18/1996 SUPPL1
`
`Labeling
`
`Showing 1 to 13 of 13 entries
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`Labels for NDA 020444
`
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`Therapeutic Equivalents for NDA 020444
`
`
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