NDA 20883, held by Sandoz. Argatroban.
As of Nov 13, 2026, NDA 20883 (Argatroban), held by Sandoz, was first approved by FDA on Jun 30, 2000, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 5, 2008 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Apr 3, 2002 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Jun 30, 2000 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Argatroban250MG/2.5ML (100MG/ML) · injectable;injection | Argatroban | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 16, 2026 | Supplement 21Labeling · Standard review | Approved | |
| Aug 8, 2017 | Supplement 19Labeling · Standard review | Approved | |
| May 25, 2016 | Supplement 18Labeling · Standard review | Approved | |
| Jan 26, 2016 | Supplement 15Manufacturing | Approved | None posted |
| Mar 10, 2014 | Supplement 16Labeling · Standard review | Approved | |
| May 5, 2008 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Sep 1, 2005 | Supplement 9Labeling · Standard review | Approved | |
| Apr 11, 2005 | Supplement 10Labeling · Standard review | Approved | |
| Oct 29, 2003 | Supplement 7Labeling · Standard review | Approved | |
| Jul 1, 2002 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Apr 3, 2002 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Aug 22, 2000 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 30, 2000 | Original applicationNew molecular entity · Standard review | Approved |
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
