Drugs@FDA: FDA Approved Drug Products

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