← FDA DRUG APPROVALS

FDA NDA · NDA021671

DEPODUR

Sponsor: PACIRA PHARMS INC

APPLICATION
NDA021671
TYPE
NDA
ORIGINAL APPROVAL
2004-05-18
LATEST ACTION
2009-09-25
ROUTE
EPIDURAL
DOSAGE FORM
INJECTABLE, LIPOSOMAL
MARKETING STATUS
Discontinued

Products

DEPODURDiscontinued
MORPHINE SULFATE 15MG/1.5ML (10MG/ML) · INJECTABLE, LIPOSOMAL · EPIDURAL
DEPODURDiscontinued
MORPHINE SULFATE 20MG/2ML (10MG/ML) · INJECTABLE, LIPOSOMAL · EPIDURAL
DEPODURDiscontinued
MORPHINE SULFATE 10MG/ML (10MG/ML) · INJECTABLE, LIPOSOMAL · EPIDURAL

Approval history

2009-09-25Labeling · Supplement 20 · standard — Label ↗AP
2007-12-14Labeling · Supplement 19 · standard — Letter ↗AP
2007-02-15Labeling · Supplement 15 · standard — Letter ↗AP
2007-01-17Labeling · Supplement 14 · standard — Label ↗AP
2006-05-22Labeling · Supplement 4 · standard — Label ↗AP
2004-08-11Labeling · Supplement 2 · standard — Letter ↗AP
2004-05-18Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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