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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020444
Company: GLAXOSMITHKLINE LLC

Products on NDA 020444

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	AP1	Yes	Yes
FLOLAN	EPOPROSTENOL SODIUM	EQ 1.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP1	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020444

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
08/24/2021	SUPPL-25	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020444s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020444Orig1s025ltr.pdf
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.

Labels for NDA 020444

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/24/2021	SUPPL-25	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020444s025lbl.pdf
08/24/2021	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020444s025lbl.pdf
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

Therapeutic Equivalents for NDA 020444

FLOLAN

INJECTABLE;INJECTION; EQ 0.5MG BASE/VIAL
TE Code = AP1

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	AP1	078396	MEITHEAL
FLOLAN	EPOPROSTENOL SODIUM	EQ 0.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP1	020444	GLAXOSMITHKLINE LLC

INJECTABLE;INJECTION; EQ 1.5MG BASE/VIAL
TE Code = AP1

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	AP1	078396	MEITHEAL
FLOLAN	EPOPROSTENOL SODIUM	EQ 1.5MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP1	020444	GLAXOSMITHKLINE LLC

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