Vincristine Sulfate Pfs

ANDA 75493, held by Teva Pharms USA. Vincristine Sulfate.

As of Nov 15, 2026, ANDA 75493 (Vincristine Sulfate Pfs), held by Teva Pharms USA, was first approved by FDA on Sep 1, 1999, with 8 approved supplements and 0 published complete response letters.

First approved: Sep 1, 1999
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Sep 1, 1999	Original application	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vincristine Sulfate Pfs1MG/ML · injectable;injection	Vincristine Sulfate	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Nov 25, 2020	Supplement 39Labeling · Standard review	Approved	None posted
Nov 25, 2020	Supplement 41Labeling · Standard review	Approved	None posted
Aug 31, 2015	Supplement 23Labeling	Approved	None posted
Aug 31, 2015	Supplement 29Labeling · Standard review	Approved	None posted
Aug 31, 2015	Supplement 38Labeling · Standard review	Approved	None posted
May 13, 2013	Supplement 30Labeling · Standard review	Approved	None posted
Jan 23, 2012	Supplement 22Labeling	Approved	None posted
Sep 17, 2002	Supplement 1Labeling	Approved	None posted
Sep 1, 1999	Original application	Approved	Review Letter

Identifiers

Application: ANDA 75493
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