FDA.reportPublic FDA data

Application 022496

Type
NDA
Sponsor
PACIRA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXPARELBUPIVACAINEINJECTABLE, LIPOSOMAL;INJECTION133MG/10ML (13.3MG/ML)YesYes
002EXPARELBUPIVACAINEINJECTABLE, LIPOSOMAL;INJECTION266MG/20ML (13.3MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65250-133EXPARELbupivacainePacira Pharmaceuticals Inc.NDACurrent
65250-133EXPARELbupivacainePacira Pharmaceuticals, Inc.NDACurrent
65250-133EXPARELbupivacainePacira Pharmaceuticals Inc.NDACurrent
65250-133EXPARELbupivacainePacira Pharmaceuticals Inc.NDACurrent
65250-133EXPARELbupivacainePacira Pharmaceuticals Inc.NDACurrent
65250-133EXPARELbupivacainePacira Pharmaceuticals Inc.NDACurrent
65250-133EXPARELbupivacainePacira Pharmaceuticals Inc.NDACurrent
65250-266EXPARELbupivacainePacira Pharmaceuticals Inc.NDACurrent
65250-266EXPARELbupivacainePacira Pharmaceuticals, Inc.NDACurrent
65250-266EXPARELbupivacainePacira Pharmaceuticals Inc.NDACurrent
65250-266EXPARELbupivacainePacira Pharmaceuticals Inc.NDACurrent
65250-266EXPARELbupivacainePacira Pharmaceuticals Inc.NDACurrent
65250-266EXPARELbupivacainePacira Pharmaceuticals Inc.NDACurrent
65250-266EXPARELbupivacainePacira Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80161SUPPL 2024-11-05
76682SUPPL 2023-11-29
76675SUPPL 2023-11-29
76562SUPPL 2023-11-14
76557SUPPL 2023-11-13
70677SUPPL2022-03-31
66853SUPPL2021-03-24
66850SUPPL2021-03-24
65863SUPPL2021-01-07
56403SUPPL2018-11-09
56276SUPPL2018-11-05
53635SUPPL2018-04-06
38764SUPPL2015-12-14
7462SUPPL2015-12-14
17644SUPPL2014-12-16
7461SUPPL2014-12-09
22036ORIG2012-06-04
38763ORIG2011-11-01
7460ORIG2011-10-31