Pavulon

NDA 17015, held by Organon USA Inc. Pancuronium Bromide.

As of Nov 13, 2026, NDA 17015 (Pavulon), held by Organon USA Inc, was first approved by FDA on Oct 24, 1972, with 16 approved supplements and 0 published complete response letters.

First approved: Oct 24, 1972
Review: Priority
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Oct 24, 1972	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Pavulon2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Pancuronium Bromide	DiscontinuedReference drug
Pavulon1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Pancuronium Bromide	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 24, 2010	Supplement 23Labeling · Priority review	Approved	Label Letter
Mar 22, 2000	Supplement 22Manufacturing · Priority review	Approved	None posted
May 17, 1995	Supplement 20Manufacturing · Priority review	Approved	None posted
Feb 28, 1994	Supplement 21Manufacturing · Priority review	Approved	None posted
Mar 29, 1993	Supplement 16Manufacturing · Priority review	Approved	None posted
Jul 25, 1991	Supplement 18Labeling · Priority review	Approved	None posted
Oct 5, 1990	Supplement 19Manufacturing · Priority review	Approved	None posted
Oct 8, 1987	Supplement 13Manufacturing · Priority review	Approved	None posted
Jun 27, 1986	Supplement 11Manufacturing · Priority review	Approved	None posted
Apr 2, 1986	Supplement 10Labeling · Priority review	Approved	None posted
Mar 17, 1982	Supplement 9Labeling · Priority review	Approved	None posted
Mar 17, 1982	Supplement 8Manufacturing · Priority review	Approved	None posted
Jan 26, 1977	Supplement 7Manufacturing · Priority review	Approved	None posted
Sep 22, 1975	Supplement 6Labeling · Priority review	Approved	None posted
Nov 11, 1974	Supplement 3Labeling · Priority review	Approved	None posted
Oct 8, 1974	Supplement 5Manufacturing · Priority review	Approved	None posted
Oct 24, 1972	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 17015
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