Argatroban In Sodium Chloride

As of Nov 15, 2026, NDA 22434 (Argatroban In Sodium Chloride), held by Cipla, was first approved by FDA on Jun 29, 2011, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 29, 2011
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jun 29, 2011	Original applicationNew formulation or manufacturer · Standard review	Approved	Summary Review Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Argatroban In Sodium Chloride50MG/50ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;intravenous	Argatroban	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Jun 10, 2026	Supplement 14Labeling · Standard review	Approved	Label Letter
Dec 6, 2019	Supplement 13Labeling · Standard review	Approved	Letter Label
Jun 18, 2018	Supplement 11Labeling · Standard review	Approved	Label Letter
May 26, 2016	Supplement 10Labeling · Standard review	Approved	Label Letter
Aug 18, 2015	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 5, 2015	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 9, 2014	Supplement 6Labeling · Standard review	Approved	Label Letter
Jan 16, 2014	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 10, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
May 20, 2013	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 29, 2011	Original applicationNew formulation or manufacturer · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 22434
Drugs@FDA: Overview at FDA
Company: Cipla

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