Depodur

NDA 21671, held by Pacira Pharms Inc. Morphine Sulfate.

As of Nov 14, 2026, NDA 21671 (Depodur), held by Pacira Pharms Inc, was first approved by FDA on May 18, 2004, with 6 approved supplements and 0 published complete response letters.

First approved: May 18, 2004
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
May 18, 2004	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

3 strengths and forms


Depodur10MG/ML (10MG/ML) · injectable, liposomal;epidural	Morphine Sulfate	Discontinued
Depodur15MG/1.5ML (10MG/ML) · injectable, liposomal;epidural	Morphine Sulfate	Discontinued
Depodur20MG/2ML (10MG/ML) · injectable, liposomal;epidural	Morphine Sulfate	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Sep 25, 2009	Supplement 20Labeling · Standard review	Approved	Letter Label
Dec 14, 2007	Supplement 19Labeling · Standard review	Approved	Letter Label
Feb 15, 2007	Supplement 15Labeling · Standard review	Approved	Letter Label
Jan 17, 2007	Supplement 14Labeling · Standard review	Approved	Letter Label
May 22, 2006	Supplement 4Labeling · Standard review	Approved	Letter Label
Aug 11, 2004	Supplement 2Labeling · Standard review	Approved	Letter
May 18, 2004	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21671
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