Velban

NDA 12665, held by Lilly. Vinblastine Sulfate.

As of Nov 13, 2026, NDA 12665 (Velban), held by Lilly, was first approved by FDA on Nov 25, 1965, with 34 approved supplements and 0 published complete response letters.

First approved: Nov 25, 1965
Review: Priority
Supplements approved: 34
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 35 submissions below

Date	Submission	Status	Documents
Nov 25, 1965	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Velban10MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Vinblastine Sulfate	DiscontinuedReference drug

All 35 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 40Labeling · Standard review	Approved	None posted
Dec 7, 2007	Supplement 37Labeling · Standard review	Approved	None posted
Dec 7, 2007	Supplement 36Labeling · Standard review	Approved	None posted
Dec 7, 2007	Supplement 34Labeling · Standard review	Approved	None posted
Dec 7, 2007	Supplement 26Labeling	Approved	None posted
Dec 7, 2007	Supplement 17Labeling	Approved	None posted
Dec 7, 2007	Supplement 13Labeling	Approved	None posted
Aug 24, 2000	Supplement 39Labeling · Standard review	Approved	None posted
Mar 4, 1999	Supplement 38Manufacturing · Priority review	Approved	None posted
Sep 2, 1997	Supplement 35Manufacturing · Priority review	Approved	None posted
Dec 20, 1996	Supplement 31Labeling · Standard review	Approved	None posted
Oct 21, 1996	Supplement 33Manufacturing · Priority review	Approved	None posted
Nov 6, 1995	Supplement 32Manufacturing · Priority review	Approved	None posted
Jul 5, 1995	Supplement 30Manufacturing · Priority review	Approved	None posted
Sep 7, 1993	Supplement 29Labeling · Standard review	Approved	None posted
Dec 16, 1992	Supplement 28Labeling · Standard review	Approved	None posted
Jul 31, 1992	Supplement 27Labeling	Approved	None posted
Aug 10, 1990	Supplement 24Labeling	Approved	None posted
Jun 18, 1990	Supplement 25Labeling	Approved	None posted
Jun 6, 1989	Supplement 23Labeling	Approved	None posted
Jun 6, 1989	Supplement 22Labeling	Approved	None posted
Apr 18, 1988	Supplement 21Labeling	Approved	None posted
Oct 16, 1987	Supplement 16Manufacturing · Priority review	Approved	None posted
Aug 25, 1987	Supplement 20Labeling	Approved	None posted
May 5, 1987	Supplement 18Manufacturing · Priority review	Approved	None posted
Mar 19, 1987	Supplement 19Manufacturing · Priority review	Approved	None posted
Jan 7, 1987	Supplement 15Manufacturing · Priority review	Approved	None posted
Nov 3, 1986	Supplement 11Labeling	Approved	None posted
Jun 30, 1986	Supplement 14Labeling	Approved	None posted
Jan 15, 1986	Supplement 12Manufacturing · Priority review	Approved	None posted
Jul 2, 1981	Supplement 10Manufacturing · Priority review	Approved	None posted
Jun 20, 1980	Supplement 7Manufacturing · Priority review	Approved	None posted
Jan 10, 1979	Supplement 9Manufacturing · Priority review	Approved	None posted
Sep 25, 1978	Supplement 8Labeling	Approved	None posted
Nov 25, 1965	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 12665
Drugs@FDA: Overview at FDA
Company: Lilly

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