FDA.reportPublic FDA data

Application 020971

Type
NDA
Sponsor
DEPROCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SEPTOCAINEARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)YesYes
002SEPTOCAINEARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0362-0830ZorcaineArticaine Hydrochloride and EpinephrineSeptodont, Inc.NDACurrent
0362-0830ZorcaineArticaine Hydrochloride and EpinephrineSeptodont, Inc.NDACurrent
0362-9048Septocaine and EpinephrineArticaine Hydrochloride and Epinephrine BitartrateSeptodont Inc.NDACurrent
0362-9048Septocaine and EpinephrineArticaine Hydrochloride and Epinephrine BitartrateSeptodont Inc.NDACurrent
0362-9048Septocaine and EpinephrineArticaine Hydrochloride and Epinephrine BitartrateSeptodont Inc.NDACurrent
0362-9048Septocaine and EpinephrineArticaine Hydrochloride and Epinephrine BitartrateSeptodont Inc.NDACurrent
0362-9049Septocaine and EpinephrineArticaine Hydrochloride and Epinephrine BitartrateSeptodont Inc.NDACurrent
0362-9049Septocaine and EpinephrineArticaine Hydrochloride and Epinephrine BitartrateSeptodont Inc.NDACurrent
0362-9049Septocaine and EpinephrineArticaine Hydrochloride and Epinephrine BitartrateSeptodont Inc.NDACurrent
0362-9049Septocaine and EpinephrineArticaine Hydrochloride and Epinephrine BitartrateSeptodont Inc.NDACurrent
0404-6620Articaine Hydrochloride and EpinephrineArticaine Hydrochloride and EpinephrineHenry ScheinNDACurrent
0404-6620Articaine Hydrochloride and EpinephrineArticaine Hydrochloride and EpinephrineHenry ScheinNDACurrent
0404-6620Articaine Hydrochloride and EpinephrineArticaine Hydrochloride and EpinephrineHenry ScheinNDACurrent
0404-6620Articaine Hydrochloride and EpinephrineArticaine Hydrochloride and EpinephrineHenry ScheinNDACurrent
0404-6620Articaine Hydrochloride and EpinephrineArticaine Hydrochloride and EpinephrineHenry ScheinNDACurrent
0404-6625Articaine Hydrochloride and EpinephrineArticaine Hydrochloride and EpinephrineHenry ScheinNDACurrent
0404-6625Articaine Hydrochloride and EpinephrineArticaine Hydrochloride and EpinephrineHenry ScheinNDACurrent
0404-6625Articaine Hydrochloride and EpinephrineArticaine Hydrochloride and EpinephrineHenry ScheinNDACurrent
0404-6625Articaine Hydrochloride and EpinephrineArticaine Hydrochloride and EpinephrineHenry ScheinNDACurrent
31382-830ZorcaineArticaine hydrochloride and Epinephrine BitartrateCarestream Health, Inc.NDACurrent
43128-101ARTICAINEArticaine Hydrochloride and EpinephrineNDC, Inc.NDACurrent
43128-101ARTICAINEArticaine Hydrochloride and EpinephrineNDC, Inc.NDACurrent
43128-101ARTICAINEArticaine Hydrochloride and EpinephrineNDC, Inc.NDACurrent
43128-102ARTICAINEArticaine Hydrochloride and EpinephrineNDC, Inc.NDACurrent
43128-102ARTICAINEArticaine Hydrochloride and EpinephrineNDC, Inc.NDACurrent
43128-102ARTICAINEArticaine Hydrochloride and EpinephrineNDC, Inc.NDACurrent
50227-1040ARTICAINEArticaine Hydrochloride and EpinephrinePatterson DentalNDACurrent
50227-1040ARTICAINEArticaine Hydrochloride and EpinephrinePatterson DentalNDACurrent
50227-1040ARTICAINEArticaine Hydrochloride and EpinephrinePatterson DentalNDACurrent
50227-1050ARTICAINEArticaine Hydrochloride and EpinephrinePatterson DentalNDACurrent
50227-1050ARTICAINEArticaine Hydrochloride and EpinephrinePatterson DentalNDACurrent
50227-1050ARTICAINEArticaine Hydrochloride and EpinephrinePatterson DentalNDACurrent
66312-601ArticadentArticaine hydrochloride and Epinephrine BitartrateDentsply PharmaceuticalNDACurrent
66312-601ArticadentArticaine hydrochloride and Epinephrine BitartrateDentsply PharmaceuticalANDACurrent
66312-601ArticadentArticaine hydrochloride and Epinephrine BitartrateDentsply PharmaceuticalNDACurrent
66312-602ArticadentArticaine hydrochloride and Epinephrine BitartrateDentsply PharmaceuticalANDACurrent
66312-602ArticadentArticaine hydrochloride and Epinephrine BitartrateDentsply PharmaceuticalNDACurrent
66312-602ArticadentArticaine hydrochloride and Epinephrine BitartrateDentsply PharmaceuticalNDACurrent
66975-417ARTICAINEArticaine Hydrochloride and EpinephrineBenco DentalNDACurrent
66975-417ARTICAINEArticaine Hydrochloride and EpinephrineBenco DentalNDACurrent
66975-417ARTICAINEArticaine Hydrochloride and EpinephrineBenco DentalNDACurrent
66975-418ARTICAINEArticaine Hydrochloride and EpinephrineBenco DentalNDACurrent
66975-418ARTICAINEArticaine Hydrochloride and EpinephrineBenco DentalNDACurrent
66975-418ARTICAINEArticaine Hydrochloride and EpinephrineBenco DentalNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56378SUPPL2018-11-08
56266SUPPL2018-11-05
21311SUPPL2015-01-28
21310SUPPL2015-01-28
41847SUPPL2013-06-03
21309SUPPL2013-06-03
3869SUPPL2010-11-18
35732SUPPL2010-03-03
3868SUPPL2010-02-26
26311SUPPL2006-11-14
13829SUPPL2006-11-13
3867SUPPL2005-02-08
3866SUPPL2004-10-18
21308ORIG2002-08-14
13828ORIG2000-04-03
3865ORIG2000-04-03