Priscoline

NDA 6403, held by Novartis. Tolazoline Hydrochloride.

As of Nov 14, 2026, NDA 6403 (Priscoline), held by Novartis, was first approved by FDA on Mar 17, 1948, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 17, 1948
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Feb 22, 1985	Supplement 8Efficacy (new indication or use)	Approved	None posted
Mar 17, 1948	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Priscoline25MG/ML · injectable;injection	Tolazoline Hydrochloride	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Apr 29, 2002	Supplement 21Manufacturing	Approved	None posted
Apr 29, 1999	Supplement 20Manufacturing	Approved	None posted
Oct 28, 1998	Supplement 19Manufacturing	Approved	None posted
Oct 16, 1998	Supplement 18Manufacturing	Approved	None posted
Nov 27, 1995	Supplement 17Manufacturing	Approved	None posted
Dec 8, 1994	Supplement 16Manufacturing	Approved	None posted
Oct 29, 1991	Supplement 15Manufacturing	Approved	None posted
Jan 31, 1990	Supplement 14Manufacturing	Approved	None posted
Nov 10, 1987	Supplement 13Manufacturing	Approved	None posted
Nov 10, 1987	Supplement 11Manufacturing	Approved	None posted
Oct 7, 1986	Supplement 12Manufacturing	Approved	None posted
Feb 22, 1985	Supplement 8Efficacy (new indication or use)	Approved	None posted
Mar 17, 1948	Original application	Approved	None posted

Identifiers

Application: NDA 6403
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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