Pancuronium Bromide

ANDA 72058, held by Elkins Sinn. Pancuronium Bromide.

As of Nov 14, 2026, ANDA 72058 (Pancuronium Bromide), held by Elkins Sinn, was first approved by FDA on Mar 23, 1988, with 9 approved supplements and 0 published complete response letters.

First approved: Mar 23, 1988
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Mar 23, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pancuronium Bromide1MG/ML · injectable;injection	Pancuronium Bromide	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Sep 10, 2001	Supplement 13Manufacturing	Approved	None posted
Sep 7, 2001	Supplement 11Manufacturing	Approved	None posted
Apr 12, 2000	Supplement 12Manufacturing	Approved	None posted
Nov 5, 1998	Supplement 9Manufacturing	Approved	None posted
Feb 19, 1993	Supplement 7Labeling	Approved	None posted
Oct 22, 1991	Supplement 5Manufacturing	Approved	None posted
Jun 7, 1991	Supplement 4Manufacturing	Approved	None posted
Dec 8, 1989	Supplement 2Labeling	Approved	None posted
Jun 17, 1988	Supplement 1Manufacturing	Approved	None posted
Mar 23, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 72058
Drugs@FDA: Overview at FDA
Company: Elkins-Sinn

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