Orinase

NDA 10670, held by Pharmacia And Upjohn. Tolbutamide.

As of Nov 13, 2026, NDA 10670 (Orinase), held by Pharmacia And Upjohn, was first approved by FDA on May 31, 1957, with 5 approved supplements and 0 published complete response letters.

First approved: May 31, 1957
Review: Priority
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
May 31, 1957	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Orinase500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Tolbutamide	Discontinued
Orinase250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Tolbutamide	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 27, 1987	Supplement 48Labeling	Approved	None posted
Dec 19, 1986	Supplement 46Labeling	Approved	None posted
Mar 24, 1986	Supplement 45Labeling	Approved	None posted
Oct 18, 1984	Supplement 44Labeling	Approved	None posted
Dec 8, 1977	Supplement 34Labeling	Approved	None posted
May 31, 1957	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 10670
Drugs@FDA: Overview at FDA
Company: Pharmacia & Upjohn

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