Last Updated: November 8, 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. Additional details are available on the FLOLAN profile page.

The generic ingredient in FLOLAN is epoprostenol sodium. There is one drug master file entry for this compound. Four 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

Medical Subject Heading (MeSH) Categories for 020444

Antihypertensive Agents
Platelet Aggregation Inhibitors

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	020444-001	Sep 20, 1995	⤷ Start Trial	⤷ Start Trial
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995	⤷ Start Trial	⤷ Start Trial
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995	⤷ Start Trial	⤷ Start Trial
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995	⤷ Start Trial	⤷ Start Trial
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995	⤷ Start Trial	⤷ Start Trial
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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