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Drugs@FDA: FDA-Approved Drugs

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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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/22/2021 SUPPL-35 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022496s035lbl.pdf
01/06/2021 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022496Orig1s036lbl.pdf
11/02/2018 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022496s030lbl.pdf
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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022496s005lbl.pdf
12/05/2014 SUPPL-5 Labeling-Package Insert 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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