Argatroban In Dextrose

NDA 201743, held by Sandoz. Argatroban.

As of Nov 13, 2026, NDA 201743 (Argatroban In Dextrose), held by Sandoz, was first approved by FDA on May 9, 2011, with 3 approved supplements and 0 published complete response letters.

First approved: May 9, 2011
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

Date	Submission	Status	Documents
May 9, 2011	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Argatroban In Dextrose125MG/125ML (1MG/ML) · solution;intravenous	Argatroban	Discontinued

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 3, 2026	Supplement 3Labeling · Standard review	Approved	Label Letter
Jun 22, 2018	Supplement 2Labeling · Standard review	Approved	Letter Label
May 26, 2016	Supplement 1Labeling · Standard review	Approved	Label Letter
May 9, 2011	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 201743
Drugs@FDA: Overview at FDA
Company: Sandoz

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