FDA.reportPublic FDA data

Application 078959

Type
ANDA
Sponsor
SEPTODONT INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEEPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.005MG/ML;4%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0362-9013Prilocaine Hydrochloride with Epinephrineprilocaine and epinephrineSeptodont Inc.ANDACurrent
66312-580Citanest Forte DENTALprilocaine HCl and epinephrineDentsply Pharmaceutical Inc.ANDACurrent
66312-580Citanest Forte DENTALprilocaine HCl and epinephrineDentsply Pharmaceutical Inc.ANDACurrent
66312-580Citanest Forte DENTALprilocaine hcl and epinephrineDentsply Pharmaceutical Inc.ANDACurrent