Fludara

NDA 20038, held by Genzyme Corp. Fludarabine Phosphate.

As of Nov 14, 2026, NDA 20038 (Fludara), held by Genzyme Corp, was first approved by FDA on Apr 18, 1991, with 22 approved supplements and 0 published complete response letters.

First approved: Apr 18, 1991
Review: Priority
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Aug 1, 2003	Supplement 28Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review
Apr 18, 1991	Original applicationNew molecular entity · Priority review	Approved	Pediatric Medical Review Pediatric Written Request

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fludara50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Fludarabine Phosphate	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Jul 29, 2010	Supplement 33Labeling · Priority review	Approved	Letter Label
Feb 10, 2009	Supplement 32Labeling · Priority review	Approved	Letter Label
Dec 20, 2007	Supplement 31Labeling · Priority review	Approved	Letter Label
Aug 1, 2003	Supplement 28Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review
Jul 2, 2002	Supplement 22Manufacturing · Priority review	Approved	None posted
Jul 2, 2002	Supplement 21Manufacturing · Priority review	Approved	None posted
May 1, 2002	Supplement 25Manufacturing · Priority review	Approved	None posted
May 1, 2002	Supplement 24Manufacturing · Priority review	Approved	None posted
Mar 28, 2002	Supplement 23Manufacturing · Priority review	Approved	None posted
Dec 3, 2001	Supplement 19Labeling · Priority review	Approved	Label
Mar 8, 2000	Supplement 20Manufacturing · Priority review	Approved	None posted
May 24, 1999	Supplement 17Labeling · Priority review	Approved	None posted
Sep 5, 1996	Supplement 18Manufacturing · Priority review	Approved	None posted
Jan 29, 1996	Supplement 15Manufacturing · Priority review	Approved	None posted
Sep 26, 1994	Supplement 14Labeling · Priority review	Approved	None posted
May 21, 1993	Supplement 13Manufacturing · Priority review	Approved	None posted
Jan 7, 1993	Supplement 8Manufacturing · Priority review	Approved	None posted
Jan 7, 1993	Supplement 7Manufacturing · Priority review	Approved	None posted
Oct 28, 1992	Supplement 11Labeling · Priority review	Approved	None posted
Apr 2, 1992	Supplement 6Labeling · Priority review	Approved	None posted
Dec 4, 1991	Supplement 5Manufacturing · Priority review	Approved	None posted
Dec 4, 1991	Supplement 3Manufacturing · Priority review	Approved	None posted
Apr 18, 1991	Original applicationNew molecular entity · Priority review	Approved	Pediatric Medical Review Pediatric Written Request

Identifiers

Application: NDA 20038
Drugs@FDA: Overview at FDA
Company: Genzyme

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