Depocyt

NDA 21041, held by Pacira Pharms Inc. Cytarabine.

As of Nov 14, 2026, NDA 21041 (Depocyt), held by Pacira Pharms Inc, was first approved by FDA on Apr 1, 1999, with 16 approved supplements and 0 published complete response letters.

First approved: Apr 1, 1999
Review: Priority
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Apr 19, 2007	Supplement 18Efficacy (new indication or use)	Approved	Letter Label
Apr 1, 1999	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Depocyt10MG/ML · injectable, liposomal;injection	Cytarabine	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements


Jan 26, 2017	Supplement 38Manufacturing · Standard review	Approved	None posted
Sep 18, 2015	Supplement 35Manufacturing · Priority review	Approved	None posted
Aug 4, 2015	Supplement 34Manufacturing · Priority review	Approved	None posted
Mar 16, 2015	Supplement 32Manufacturing · Priority review	Approved	None posted
Dec 23, 2014	Supplement 31Labeling · Standard review	Approved	Label Letter
Aug 13, 2014	Supplement 29Manufacturing · Priority review	Approved	None posted
Apr 23, 2014	Supplement 27Manufacturing · Priority review	Approved	None posted
Apr 23, 2014	Supplement 28Manufacturing · Priority review	Approved	None posted
Aug 9, 2013	Supplement 26Manufacturing · Priority review	Approved	None posted
Aug 11, 2011	Supplement 23Labeling · Standard review	Approved	Letter Label
Apr 19, 2007	Supplement 18Efficacy (new indication or use)	Approved	Letter Label
Oct 2, 2003	Supplement 8Manufacturing · Priority review	Approved	Letter
Oct 2, 2003	Supplement 10Labeling · Standard review	Approved	Letter
Dec 31, 2002	Supplement 6Manufacturing · Priority review	Approved	None posted
Mar 1, 2001	Supplement 4Manufacturing · Priority review	Approved	None posted
Jan 5, 2001	Supplement 3Manufacturing · Priority review	Approved	None posted
Apr 1, 1999	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 21041
Drugs@FDA: Overview at FDA
Company: Pacira Pharmaceuticals, Inc.

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