Viadur

NDA 21088, held by Ortho Mcneil Janssen. Leuprolide Acetate.

As of Nov 14, 2026, NDA 21088 (Viadur), held by Ortho Mcneil Janssen, was first approved by FDA on Mar 3, 2000, with 17 approved supplements and 0 published complete response letters.

First approved: Mar 3, 2000
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Mar 3, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
ViadurEQ 65MG BASE · implant;implantation	Leuprolide Acetate	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Jan 14, 2011	Supplement 25Labeling · Standard review	Approved	Label Letter
Sep 15, 2005	Supplement 22Labeling · Standard review	Approved	Letter Label
Sep 8, 2005	Supplement 7Labeling · Standard review	Approved	Label Letter
Aug 1, 2003	Supplement 15Labeling · Standard review	Approved	Letter
Oct 21, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 23, 2002	Supplement 13Manufacturing · Standard review	Approved	None posted
May 23, 2002	Supplement 14Manufacturing · Standard review	Approved	None posted
May 23, 2002	Supplement 12Manufacturing · Standard review	Approved	None posted
May 17, 2002	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 13, 2001	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 8, 2001	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 5, 2001	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 8, 2001	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 24, 2001	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 16, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 28, 2000	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 18, 2000	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 3, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21088
Drugs@FDA: Overview at FDA
Company: Ortho-McNeil-Janssen Pharmaceuticals

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