Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021671
Company: PACIRA PHARMS INC
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 |