← FDA DRUG APPROVALS

FDA NDA · NDA021321

EXTRANEAL

icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

Sponsor: VANTIVE US HLTHCARE

APPLICATION
NDA021321
TYPE
NDA
ORIGINAL APPROVAL
2002-12-20
LATEST ACTION
2024-04-22
ROUTE
INTRAPERITONEAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

EXTRANEAL · ReferencePrescription
ICODEXTRIN 7.5GM/100ML · SOLUTION · INTRAPERITONEAL

Approval history

2024-04-22Labeling · Supplement 38 · standard — Letter ↗AP
2019-12-04REMS · Supplement 37 — Letter ↗AP
2016-12-16Labeling · Supplement 34 · standard — Label ↗AP
2016-10-24REMS · Supplement 35 — Letter ↗AP
2016-08-01Manufacturing (CMC) · Supplement 33 · standardAP
2015-10-16REMS · Supplement 32 — Letter ↗AP
2014-12-09Labeling · Supplement 28 · standard — Letter ↗AP
2014-02-25REMS · Supplement 29 — Letter ↗AP
2014-02-04Manufacturing (CMC) · Supplement 30 · standardAP
2013-04-26Manufacturing (CMC) · Supplement 26 · standardAP
2011-03-09REMS · Supplement 20 · standard — Label ↗AP
2011-03-09Labeling · Supplement 21 · unknown — Letter ↗AP
2009-04-07Labeling · Supplement 17 · 901 required — Letter ↗AP
2009-01-29Manufacturing (CMC) · Supplement 18 — Letter ↗AP
2007-02-23Labeling · Supplement 13 · standard — Letter ↗AP
2005-05-24Manufacturing (CMC) · Supplement 8 · standard — Letter ↗AP
2005-05-24Labeling · Supplement 9 · standard — Letter ↗AP
2004-12-17Efficacy · Supplement 10 · priority — Label ↗AP
2002-12-20Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →