Arduan

NDA 19638, held by Organon USA Inc. Pipecuronium Bromide.

As of Nov 14, 2026, NDA 19638 (Arduan), held by Organon USA Inc, was first approved by FDA on Jun 26, 1990, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 26, 1990
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jun 26, 1990	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Arduan10MG/VIAL · injectable;injection	Pipecuronium Bromide	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Nov 22, 2010	Supplement 5Labeling · Standard review	Approved	Letter
May 5, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 28, 1994	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 18, 1993	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 24, 1991	Supplement 1Labeling · Standard review	Approved	None posted
Jun 26, 1990	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19638
Drugs@FDA: Overview at FDA
Company: Organon USA

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