Application 204803

Type
NDA
Sponsor
DURECT CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POSIMIRBUPIVACAINEINJECTABLE;INJECTION132MG/MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49396-6601POSIMIRBupivacaineRenaissance Lakewood, LLCNDACurrent
51715-660POSIMIRbupivacaineINNOCOLL PHARMACEUTICALSNDACurrent
51715-660POSIMIRbupivacaineINNOCOLL PHARMACEUTICALSNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71731SUPPL2022-08-05
71720SUPPL2022-08-04
71163ORIG2022-05-31
66072ORIG2021-02-03
66054ORIG2021-02-02