FDA.reportPublic FDA data

Application 088390

Type
ANDA
Sponsor
DEPROCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIGNOSPAN STANDARDEPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 0.01MG BASE/ML;2%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0362-0898LidocaineLidocaine Hydrochloride and EpinephrineSeptodont, Inc.ANDACurrent
0362-0898LidocaineLidocaine Hydrochloride and EpinephrineSeptodont, Inc.ANDACurrent
0362-1095Lignospan StandardLidocaine Hydrochloride and EpinephrineSeptodont, Inc.ANDACurrent
0362-1095Lignospan StandardLidocaine Hydrochloride and EpinephrineSeptodont, Inc.ANDACurrent
0362-1095Lignospan StandardLidocaine Hydrochloride and EpinephrineSeptodont, Inc.ANDACurrent
0362-1095Lignospan StandardLidocaine Hydrochloride and EpinephrineSeptodont, Inc.ANDACurrent
0362-9023Octocaine 100Lidocaine Hydrochloride and Epinephrine BitartrateSeptodontANDACurrent
0404-6512LidocaineLidocaine Hydrochloride and Epinephrine BitartrateHenry Schein Inc.ANDACurrent
0404-6512LidocaineLidocaine Hydrochloride and Epinephrine BitartrateHenry Schein Inc.ANDACurrent
0404-6512LIDOCAINELidocaine Hydrochloride and Epinephrine BitartrateHenry ScheinANDACurrent
0404-6512LidocaineLidocaine Hydrochloride and Epinephrine BitartrateHenry Scein IncANDACurrent
0404-6512LidocaineLidocaine Hydrochloride and Epinephrine BitartrateHenry Scein IncANDACurrent
0404-6512LidocaineLidocaine Hydrochloride and Epinephrine BitartrateHenry Schein Inc.ANDACurrent
31382-898LidocaineLidocaine Hydrochloride and Epinephrine BitartrateCareStream Health, Inc.ANDACurrent
42756-1030Lidocaine Hydrochloride and Epinephrine BitartrateLidocaine Hydrochloride and Epinephrine BitartrateIQ DentalANDACurrent
42756-1030Lidocaine Hydrochloride and Epinephrine BitartrateLidocaine Hydrochloride and Epinephrine BitartrateIQ DentalANDACurrent
43128-105LIDOCAINELidocaine Hydrochloride and Epinephrine BitartrateNDC, Inc.ANDACurrent
43128-105LIDOCAINELidocaine Hydrochloride and Epinephrine BitartrateNDC, Inc.ANDACurrent
43305-1030LIDOCAINE HClLidocaine Hydrochloride and Epinephrine BitartratePearson DentalANDACurrent
50227-1030LIDOCAINELidocaine Hydrochloride and Epinephrine BitartratePatterson DentalANDACurrent
50227-1030LIDOCAINELidocaine Hydrochloride and Epinephrine BitartratePatterson DentalANDACurrent
51004-1051LIDOCAINELidocaine Hydrochloride and Epinephrine BitartrateNovocol Pharmaceutical of Canada, Inc.ANDACurrent
51004-1095Lignospan StandardLidocaine Hydrochloride and Epinephrine BitartrateNovocol Pharmaceutical of Canada, Inc.ANDACurrent
51004-2010Lidocaine Hydrochloride and Epinephrine BitartrateLidocaine Hydrochloride and Epinephrine BitartrateNovocol Pharmaceutical of Canada, Inc.ANDACurrent
66312-176XylocaineLidocaine Hydrochloride and Epinephrine BitartrateDentsply PharmaceuticalANDACurrent
66312-176XylocaineLidocaine Hydrochloride and Epinephrine BitartrateDentsply PharmaceuticalANDACurrent
66312-176XylocaineLidocaine Hydrochloride and Epinephrine BitartrateDentsply PharmaceuticalANDACurrent
66467-9730LidocaineLidocaine Hydrochloride and Epinephrine BitartrateDarby Dental Supply, LLCANDACurrent
66467-9730LidocaineLidocaine Hydrochloride and Epinephrine BitartrateDarby Dental Supply, LLCANDACurrent
66975-425LidocaineLidocaine Hydrochloride and Epinephrine BitartrateBenco DentalANDACurrent
66975-425LidocaineLidocaine Hydrochloride and Epinephrine BitartrateBenco DentalANDACurrent
67239-0240LidocaineLidocaine Hydrochloride and Epinephrine BitartrateSafco Dental Supply CoANDACurrent
67239-0240LidocaineLidocaine Hydrochloride and Epinephrine BitartrateSafco Dental Supply CoANDACurrent
71347-210LidocaineLidocaine Hydrochloride and Epinephrine BitartrateThe Atlanta Dental Supply Company DBA Advanced Dental ProductsANDACurrent
71347-210LidocaineLidocaine Hydrochloride and Epinephrine BitartrateThe Atlanta Dental Supply Company DBA Advanced Dental ProductsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83016SUPPL 2025-08-01
83015SUPPL 2025-08-01