Bal

NDA 5939, held by Provepharm Sas. Dimercaprol.

As of Nov 13, 2026, NDA 5939 (Bal), held by Provepharm Sas, was first approved by FDA on May 6, 1946, with 6 approved supplements and 0 published complete response letters.

First approved: May 6, 1946
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
May 6, 1946	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bal10% · injectable;injection	Dimercaprol	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Mar 18, 2026	Supplement 18Labeling · Standard review	Approved	Label Letter
Mar 4, 2026	Supplement 17Labeling · Standard review	Approved	Label Letter
Aug 8, 2022	Supplement 12Manufacturing	Tentative approval	Letter
Apr 18, 2007	Supplement 7Labeling · Standard review	Approved	Letter Label
Sep 26, 2006	Supplement 6Manufacturing	Approved	None posted
Dec 27, 1988	Supplement 3Manufacturing	Approved	None posted
Jul 29, 1977	Supplement 2Labeling	Approved	None posted
May 6, 1946	Original application	Approved	None posted

Identifiers

Application: NDA 5939
Drugs@FDA: Overview at FDA
Company: Provepharm Inc.

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

Bal