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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021671
Company: PACIRA PHARMS INC

Products on NDA 021671

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEPODUR	MORPHINE SULFATE	10MG/ML (10MG/ML)	INJECTABLE, LIPOSOMAL;EPIDURAL	Discontinued	None	No	No
DEPODUR	MORPHINE SULFATE	15MG/1.5ML (10MG/ML)	INJECTABLE, LIPOSOMAL;EPIDURAL	Discontinued	None	No	No
DEPODUR	MORPHINE SULFATE	20MG/2ML (10MG/ML)	INJECTABLE, LIPOSOMAL;EPIDURAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021671

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/18/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21671_depoDur_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21671ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021671_s000_DepoDurTOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/25/2009	SUPPL-20	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021671s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021671s020ltr.pdf
12/14/2007	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021671s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021671s019ltr.pdf
02/15/2007	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021671s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021671s015ltr.pdf
01/17/2007	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021671s014_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021671s014ltr.pdf
05/22/2006	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021671s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021671s004LTR.pdf
08/11/2004	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21671s002ltr.pdf

Labels for NDA 021671

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/25/2009	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021671s020lbl.pdf
12/14/2007	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021671s019lbl.pdf
02/15/2007	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021671s015lbl.pdf
01/17/2007	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021671s014_LBL.pdf
05/22/2006	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021671s004lbl.pdf
05/18/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21671_depoDur_lbl.pdf

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