Orgaran

NDA 20430, held by Aspen Global Inc. Danaparoid Sodium.

As of Nov 13, 2026, NDA 20430 (Orgaran), held by Aspen Global Inc, was first approved by FDA on Dec 24, 1996, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 24, 1996
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below


Jun 26, 2001	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Dec 24, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Orgaran750 UNITS/0.6ML · injectable;injection	Danaparoid Sodium	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jun 26, 2001	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Jan 30, 1998	Supplement 2Labeling · Standard review	Approved	None posted
Jul 16, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 24, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20430
Drugs@FDA: Overview at FDA
Company: Aspen Global Inc

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