Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021041
Company: PACIRA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEPOCYT CYTARABINE 10MG/ML INJECTABLE, LIPOSOMAL;INJECTION Discontinued None Yes 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
04/01/1999 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21041ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-041_DepoCyt.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/26/2017 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

09/18/2015 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

08/04/2015 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

03/16/2015 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/23/2014 SUPPL-31 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021041s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021041Orig1s031ltr.pdf
08/13/2014 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/23/2014 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/23/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/09/2013 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/11/2011 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021041s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021041s023ltr.pdf
04/19/2007 SUPPL-18 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021041s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021041s018_LTR.pdf
10/02/2003 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21041scp008,010ltr.pdf
10/02/2003 SUPPL-8 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21041scp008,010ltr.pdf
12/31/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/23/2014 SUPPL-31 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021041s031lbl.pdf
12/23/2014 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021041s031lbl.pdf
08/11/2011 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021041s023lbl.pdf
04/19/2007 SUPPL-18 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021041s018lbl.pdf
04/01/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21041lbl.pdf

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