FDA.reportPublic FDA data

Application 088389

Type
ANDA
Sponsor
DEPROCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIGNOSPAN FORTEEPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 0.02MG BASE/ML;2%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0362-0262LidocaineLidocaine Hydrochloride and EpinephrineSeptodont, Inc.ANDACurrent
0362-0262LidocaineLidocaine Hydrochloride and EpinephrineSeptodont, Inc.ANDACurrent
0362-1096Lignospan ForteLidocaine Hydrochloride and EpinephrineSeptodont, Inc.ANDACurrent
0362-1096Lignospan ForteLidocaine Hydrochloride and EpinephrineSeptodont, Inc.ANDACurrent
0362-1096Lignospan ForteLidocaine Hydrochloride and EpinephrineSeptodont, Inc.ANDACurrent
0362-1096Lignospan ForteLidocaine Hydrochloride and EpinephrineSeptodont, Inc.ANDACurrent
0362-9010Octocaine 50Lidocaine Hydrochloride and Epinephrine BitartrateSeptodontANDACurrent
0404-6500LIDOCAINELidocaine Hydrochloride and Epinephrine BitartrateHenry Schein Inc.ANDACurrent
0404-6500LIDOCAINELidocaine Hydrochloride and Epinephrine BitartrateHenry Schein Inc.ANDACurrent
31382-262LidocaineLidocaine Hydrochloride and Epinephrine BitartrateCareStream Health, Inc.ANDACurrent
50227-1020LidocaineLidocaine Hydrochloride and Epinephrine BitartratePatterson DentalANDACurrent
50227-1020LidocaineLidocaine Hydrochloride and Epinephrine BitartratePatterson DentalANDACurrent
51004-0550LidocaineLidocaine Hydrochloride and Epinephrine BitartrateNovocol Pharmaceutical of Canada, Inc.ANDACurrent
51004-1096Lignospan ForteLidocaine Hydrochloride and Epinephrine BitartrateNovocol Pharmaceutical of Canada, Inc.ANDACurrent
66312-181XylocaineLidocaine Hydrochloride and Epinephrine BitartrateDentsply PharmaceuticalANDACurrent
66312-181XylocaineLidocaine Hydrochloride and Epinephrine BitartrateDentsply PharmaceuticalANDACurrent
66312-181XylocaineLidocaine Hydrochloride and Epinephrine BitartrateDentsply PharmaceuticalANDACurrent
66467-9710LidocaineLidocaine Hydrochloride and Epinephrine BitartrateDarby Dental Supply, LLCANDACurrent
66467-9710LidocaineLidocaine Hydrochloride and Epinephrine BitartrateDarby Dental Supply, LLCANDACurrent
66975-415LidocaineLidocaine Hydrochloride and Epinephrine BitartrateBenco DentalANDACurrent
66975-415LidocaineLidocaine Hydrochloride and Epinephrine BitartrateBenco DentalANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83017SUPPL 2025-08-01
83014SUPPL 2025-08-01