Anturane

NDA 11556, held by Novartis. Sulfinpyrazone.

As of Nov 14, 2026, NDA 11556 (Anturane), held by Novartis, was first approved by FDA on May 13, 1959, with 23 approved supplements and 0 published complete response letters.

First approved: May 13, 1959
Review: Standard
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
May 13, 1959	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


Anturane100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Sulfinpyrazone	Discontinued
Anturane200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Sulfinpyrazone	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements


Aug 26, 2002	Supplement 53Labeling · Standard review	Approved	Letter
Apr 22, 1999	Supplement 54Manufacturing · Standard review	Approved	None posted
Sep 12, 1998	Supplement 52Manufacturing · Standard review	Approved	None posted
Jan 4, 1993	Supplement 51Manufacturing · Standard review	Approved	None posted
Oct 20, 1992	Supplement 50Manufacturing · Standard review	Approved	None posted
Jun 13, 1990	Supplement 49Manufacturing · Standard review	Approved	None posted
Jul 8, 1987	Supplement 48Manufacturing · Standard review	Approved	None posted
Mar 17, 1987	Supplement 46Manufacturing · Standard review	Approved	None posted
Dec 8, 1986	Supplement 44Manufacturing · Standard review	Approved	None posted
Sep 2, 1986	Supplement 47Manufacturing · Standard review	Approved	None posted
Apr 7, 1986	Supplement 45Labeling	Approved	None posted
Oct 8, 1985	Supplement 41Manufacturing · Standard review	Approved	None posted
Sep 30, 1985	Supplement 43Manufacturing · Standard review	Approved	None posted
Feb 27, 1985	Supplement 42Manufacturing · Standard review	Approved	None posted
Jun 12, 1984	Supplement 38Labeling	Approved	None posted
Apr 9, 1983	Supplement 40Manufacturing · Standard review	Approved	None posted
Oct 27, 1980	Supplement 36Manufacturing · Standard review	Approved	None posted
Feb 26, 1980	Supplement 37Manufacturing · Standard review	Approved	None posted
Sep 7, 1979	Supplement 35Manufacturing · Standard review	Approved	None posted
Jul 20, 1979	Supplement 33Manufacturing · Standard review	Approved	None posted
Jul 20, 1979	Supplement 34Manufacturing · Standard review	Approved	None posted
Sep 26, 1978	Supplement 31Manufacturing · Standard review	Approved	None posted
Aug 29, 1978	Supplement 32Manufacturing · Standard review	Approved	None posted
May 13, 1959	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 11556
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