Zanosar

NDA 50577, held by Teva Pharms USA. Streptozocin.

As of Nov 14, 2026, NDA 50577 (Zanosar), held by Teva Pharms USA, was first approved by FDA on May 7, 1982, with 21 approved supplements and 0 published complete response letters.

First approved: May 7, 1982
Review: Standard
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
May 7, 1982	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Zanosar1GM/VIAL · injectable;injection	Streptozocin	DiscontinuedReference drug

All 22 submissions, including labeling and manufacturing supplements


Nov 14, 2016	Supplement 42Manufacturing · Standard review	Approved	None posted
Jan 5, 2015	Supplement 41Manufacturing · Standard review	Approved	None posted
Jan 5, 2015	Supplement 40Manufacturing · Standard review	Approved	None posted
Sep 23, 2014	Supplement 39Manufacturing · Standard review	Approved	None posted
Jul 31, 2014	Supplement 38Manufacturing · Standard review	Approved	None posted
Aug 9, 2013	Supplement 36Manufacturing · Standard review	Approved	None posted
Dec 12, 2012	Supplement 37Manufacturing · Standard review	Approved	None posted
Dec 4, 2012	Supplement 35Manufacturing · Standard review	Approved	None posted
Dec 4, 2012	Supplement 34Manufacturing · Standard review	Approved	None posted
Dec 4, 2012	Supplement 20Manufacturing · Standard review	Approved	None posted
Jan 22, 2003	Supplement 16Labeling · Standard review	Approved	Letter
Dec 30, 2002	Supplement 14Labeling · Standard review	Approved	Letter
Oct 22, 2002	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 3, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
May 5, 1999	Supplement 13Labeling · Standard review	Approved	None posted
Jun 29, 1995	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 27, 1994	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 11, 1994	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 14, 1993	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 22, 1988	Supplement 6Labeling	Approved	None posted
Nov 17, 1986	Supplement 5Labeling	Approved	None posted
May 7, 1982	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 50577
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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