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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021041
Company: PACIRA PHARMS INC

Products on NDA 021041

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021041

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.html

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.

Labels for NDA 021041

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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