← FDA DRUG APPROVALS

FDA NDA · NDA020444

FLOLAN

Sponsor: GLAXOSMITHKLINE LLC

APPLICATION
NDA020444
TYPE
NDA
ORIGINAL APPROVAL
1995-09-20
LATEST ACTION
2021-08-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

FLOLAN · ReferenceDiscontinued
EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL · INJECTABLE · INJECTION
FLOLAN · ReferenceDiscontinued
EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2021-08-24Labeling · Supplement 25 · standard — Letter ↗AP
2018-12-12Labeling · Supplement 24 · standard — Label ↗AP
2018-10-23Labeling · Supplement 23 · standard — Label ↗AP
2018-05-14Labeling · Supplement 22 · standard — Letter ↗AP
2015-04-17Manufacturing (CMC) · Supplement 21 · priority — Label ↗AP
2011-03-29Labeling · Supplement 18 · unknown — Letter ↗AP
2008-03-12Labeling · Supplement 16 · standard — Label ↗AP
2002-09-20Manufacturing (CMC) · Supplement 10 · priorityAP
2002-06-21Manufacturing (CMC) · Supplement 9 · priorityAP
2002-06-21Manufacturing (CMC) · Supplement 8 · priorityAP
2002-04-05Manufacturing (CMC) · Supplement 7 · priorityAP
2002-01-17Manufacturing (CMC) · Supplement 6 · priorityAP
2000-09-21Labeling · Supplement 5 · standardAP
2000-04-14Efficacy · Supplement 3 · priority — Review ↗AP
1999-11-02Labeling · Supplement 4 · standardAP
1997-11-21Manufacturing (CMC) · Supplement 2 · priorityAP
1996-03-18Labeling · Supplement 1 · standardAP
1995-09-20Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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