FDA.reportPublic FDA data

Application 077250

Type
ANDA
Sponsor
SEPTODONT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION0.5%;0.0091MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0362-0557Marcainebupivacaine hydrochloride and epinephrine bitartrateSeptodont, Inc.ANDACurrent
0362-0557Marcainebupivacaine hydrochloride and epinephrine bitartrateSeptodont, Inc.ANDACurrent
0362-9011Vivacainebupivacaine hydrochloride and epinephrine bitartrateSeptodont, Inc.ANDACurrent
0362-9011Vivacainebupivacaine hydrochloride and epinephrine bitartrateSeptodont, Inc.ANDACurrent
0362-9011Vivacainebupivacaine hydrochloride and epinephrine bitartrateSeptodont, Inc.ANDACurrent
0362-9011Vivacainebupivacaine hydrochloride and epinephrine bitartrateSeptodont Inc.ANDACurrent
0362-9011Vivacainebupivacaine hydrochloride and epinephrine bitartrateSeptodont, Inc.ANDACurrent
0362-9011Vivacainebupivacaine hydrochloride and epinephrine bitartrateSeptodont, Inc.ANDACurrent
31382-557Marcainebupivacaine hydrochloride and epinephrine bitartrateCarestream Health Inc.ANDACurrent