Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022496
Company: PACIRA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EXPAREL BUPIVACAINE 133MG/10ML (13.3MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription None Yes Yes
EXPAREL BUPIVACAINE 266MG/20ML (13.3MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/28/2011 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022496s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022496s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022496Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/08/2017 SUPPL-23 Labeling-Container/Carton Labels

Label is not available on this site.

06/10/2016 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/14/2015 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022496s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022496Orig1s019ltr.pdf
04/15/2016 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/05/2016 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/08/2015 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/11/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/27/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/27/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/15/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/06/2018 SUPPL-9 Efficacy-New Indication Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022496s009lbledt.pdf
08/13/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/05/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/28/2014 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/05/2014 SUPPL-5 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022496s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022496Orig1s005ltr.pdf
07/10/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/06/2018 SUPPL-9 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022496s009lbledt.pdf
12/14/2015 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022496s019lbl.pdf
12/05/2014 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022496s005lbl.pdf
12/05/2014 SUPPL-5 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022496s005lbl.pdf
10/28/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022496s000lbl.pdf

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