Tandearil

NDA 12542, held by Novartis. Oxyphenbutazone.

As of Nov 14, 2026, NDA 12542 (Tandearil), held by Novartis, was first approved by FDA on Dec 21, 1960, with 18 approved supplements and 0 published complete response letters.

First approved: Dec 21, 1960
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Dec 21, 1960	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tandearil100MG · tablet;oral	Oxyphenbutazone	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Mar 25, 1985	Supplement 56Labeling · Standard review	Approved	None posted
Aug 13, 1984	Supplement 55Manufacturing · Standard review	Approved	None posted
Feb 25, 1983	Supplement 52Manufacturing · Standard review	Approved	None posted
Sep 14, 1982	Supplement 51Manufacturing · Standard review	Approved	None posted
Sep 3, 1982	Supplement 47Manufacturing · Standard review	Approved	None posted
Jul 25, 1980	Supplement 50Manufacturing · Standard review	Approved	None posted
Sep 6, 1979	Supplement 49Labeling · Standard review	Approved	None posted
Aug 8, 1979	Supplement 48Manufacturing · Standard review	Approved	None posted
Apr 26, 1979	Supplement 43Manufacturing · Standard review	Approved	None posted
Apr 26, 1979	Supplement 40Manufacturing · Standard review	Approved	None posted
Feb 9, 1979	Supplement 41Manufacturing · Standard review	Approved	None posted
Nov 8, 1978	Supplement 46Manufacturing · Standard review	Approved	None posted
Feb 28, 1978	Supplement 42Labeling · Standard review	Approved	None posted
Jan 5, 1978	Supplement 37Labeling · Standard review	Approved	None posted
Dec 16, 1977	Supplement 45Labeling · Standard review	Approved	None posted
Dec 16, 1977	Supplement 44Labeling · Standard review	Approved	None posted
Nov 29, 1977	Supplement 39Manufacturing · Standard review	Approved	None posted
Apr 29, 1977	Supplement 36Manufacturing · Standard review	Approved	None posted
Dec 21, 1960	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 12542
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