Drugs@FDA: FDA-Approved Drugs
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 |