Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020444
Company: GLAXOSMITHKLINE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLOLAN EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
FLOLAN EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/20/1995 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020444Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/12/2018 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020444s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020444Orig1s024ltr.pdf
10/23/2018 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020444s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020444Orig1s023ltr.pdf
05/14/2018 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020444s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020444Orig1s022ltr.pdf
04/17/2015 SUPPL-21 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020444s021lbl.pdf
03/29/2011 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020444s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020444s018ltr.pdf
03/12/2008 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020444s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020444s016ltr.pdf
09/20/2002 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/21/2002 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/21/2002 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/05/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/17/2002 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/21/2000 SUPPL-5 Labeling

Label is not available on this site.

11/02/1999 SUPPL-4 Labeling

Label is not available on this site.

04/14/2000 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20444S03LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20444S03LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-444S003_Flolan.cfm
11/21/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/18/1996 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/12/2018 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020444s024lbl.pdf
10/23/2018 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020444s023lbl.pdf
05/14/2018 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020444s022lbl.pdf
04/17/2015 SUPPL-21 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020444s021lbl.pdf
03/29/2011 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020444s018lbl.pdf
03/12/2008 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020444s016lbl.pdf
04/14/2000 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20444S03LBL.PDF

FLOLAN

INJECTABLE;INJECTION; EQ 0.5MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EPOPROSTENOL SODIUM EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 078396 TEVA PHARMS USA
FLOLAN EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 020444 GLAXOSMITHKLINE LLC

INJECTABLE;INJECTION; EQ 1.5MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EPOPROSTENOL SODIUM EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 078396 TEVA PHARMS USA
FLOLAN EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 020444 GLAXOSMITHKLINE LLC

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