← FDA DRUG APPROVALS

FDA NDA · NDA020484

INNOHEP

Sponsor: LEO PHARMA AS

APPLICATION
NDA020484
TYPE
NDA
ORIGINAL APPROVAL
2000-07-14
LATEST ACTION
2010-10-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

INNOHEPDiscontinued
TINZAPARIN SODIUM 20,000 IU/ML · INJECTABLE · INJECTION

Approval history

2010-10-07Labeling · Supplement 14 · standard — Label ↗AP
2009-12-23Labeling · Supplement 13 · standard — Label ↗AP
2008-12-29Labeling · Supplement 11 · standard — Letter ↗AP
2006-11-07Labeling · Supplement 6 · standard — Letter ↗AP
2003-03-04Labeling · Supplement 3 · standard — Letter ↗AP
2002-02-05Labeling · Supplement 2 · standard — Letter ↗AP
2000-11-21Manufacturing (CMC) · Supplement 1 · standardAP
2000-07-14Type 1 - New Molecular Entity · Original · standard — Label ↗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 →