Innohep

NDA 20484, held by Leo Pharma As. Tinzaparin Sodium.

As of Nov 13, 2026, NDA 20484 (Innohep), held by Leo Pharma As, was first approved by FDA on Jul 14, 2000, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 14, 2000
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jul 14, 2000	Original applicationNew molecular entity · Standard review	Approved	Letter Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Innohep20,000 IU/ML · injectable;injection	Tinzaparin Sodium	Discontinued

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 7, 2010	Supplement 14Labeling · Standard review	Approved	Letter Label
Dec 23, 2009	Supplement 13Labeling · Standard review	Approved	Letter Label
Dec 29, 2008	Supplement 11Labeling · Standard review	Approved	Label Letter
Nov 7, 2006	Supplement 6Labeling · Standard review	Approved	Letter
Mar 4, 2003	Supplement 3Labeling · Standard review	Approved	Letter
Feb 5, 2002	Supplement 2Labeling · Standard review	Approved	Letter
Nov 21, 2000	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 14, 2000	Original applicationNew molecular entity · Standard review	Approved	Letter Label Review

Identifiers

Application: NDA 20484
Drugs@FDA: Overview at FDA
Company: LEO Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters