Tolbutamide

As of Nov 13, 2026, NDA 12678 (Tolbutamide), held by Sandoz, was first approved by FDA on Jul 10, 1974, with 31 approved supplements and 0 published complete response letters.

First approved: Jul 10, 1974
Review: Standard
Supplements approved: 31
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below

Date	Submission	Status	Documents
Jul 10, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tolbutamide500MG · tablet;oral	Tolbutamide	Discontinued

All 32 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 35Labeling	Approved	None posted
Dec 7, 2007	Supplement 33Labeling	Approved	None posted
Dec 7, 2007	Supplement 32Labeling	Approved	None posted
Dec 7, 2007	Supplement 31Labeling	Approved	None posted
Dec 7, 2007	Supplement 29Labeling	Approved	None posted
Dec 7, 2007	Supplement 28Labeling	Approved	None posted
Dec 7, 2007	Supplement 25Labeling	Approved	None posted
Dec 7, 2007	Supplement 24Labeling	Approved	None posted
Dec 7, 2007	Supplement 23Labeling	Approved	None posted
Dec 7, 2007	Supplement 18Labeling	Approved	None posted
Dec 7, 2007	Supplement 17Labeling	Approved	None posted
Dec 7, 2007	Supplement 16Labeling	Approved	None posted
Dec 7, 2007	Supplement 15Labeling	Approved	None posted
Dec 7, 2007	Supplement 12Labeling	Approved	None posted
Dec 7, 2007	Supplement 11Labeling	Approved	None posted
Sep 2, 1988	Supplement 42Manufacturing · Standard review	Approved	None posted
Aug 26, 1988	Supplement 43Labeling	Approved	None posted
Feb 2, 1988	Supplement 36Manufacturing · Standard review	Approved	None posted
Nov 18, 1985	Supplement 41Labeling	Approved	None posted
Jun 28, 1985	Supplement 40Manufacturing · Standard review	Approved	None posted
Apr 5, 1985	Supplement 39Labeling	Approved	None posted
Sep 21, 1983	Supplement 38Manufacturing · Standard review	Approved	None posted
Sep 21, 1983	Supplement 34Labeling	Approved	None posted
Jul 8, 1982	Supplement 37Manufacturing · Standard review	Approved	None posted
May 30, 1979	Supplement 22Labeling	Approved	None posted
May 30, 1979	Supplement 21Labeling	Approved	None posted
May 30, 1979	Supplement 20Labeling	Approved	None posted
May 30, 1979	Supplement 19Labeling	Approved	None posted
Dec 11, 1978	Supplement 26Labeling	Approved	None posted
Dec 8, 1978	Supplement 27Labeling	Approved	None posted
Jan 23, 1975	Supplement 10Labeling	Approved	None posted
Jul 10, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 12678
Drugs@FDA: Overview at FDA
Company: Sandoz

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