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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 020444

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NDA 020444 describes FLOLAN, which is a drug marketed by Glaxosmithkline Llc and is included in one NDA. It is available from one supplier. Additional details are available on the FLOLAN profile page.

The generic ingredient in FLOLAN is epoprostenol sodium. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the epoprostenol sodium profile page.

Summary for 020444

Tradename:	FLOLAN
Applicant:	Glaxosmithkline Llc
Ingredient:	epoprostenol sodium
Patents:	0

Pharmacology for NDA: 020444

Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for 020444

Antihypertensive Agents
Platelet Aggregation Inhibitors

Suppliers and Packaging for NDA: 020444

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444	NDA	GlaxoSmithKline LLC	0173-0519	0173-0519-00	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0173-0519-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.5MG BASE/VIAL
Approval Date:	Sep 20, 1995	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1.5MG BASE/VIAL
Approval Date:	Sep 20, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 020444

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995	4,883,812	⤷ Get Started Free
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995	4,335,139	⤷ Get Started Free
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995	4,335,139	⤷ Get Started Free
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995	4,338,325	⤷ Get Started Free
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995	4,539,333	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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