FDA.reportPublic FDA data

Application 088387

Type
ANDA
Sponsor
DEPROCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SCANDONEST PLAINMEPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION3%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0362-0753CarbocaineMepivacaine HydrochlorideSeptodont, Inc.ANDACurrent
0362-0753CarbocaineMepivacaine HydrochlorideSeptodont, Inc.ANDACurrent
0362-0753CarbocaineMepivacaine HydrochlorideSeptodont, Inc.ANDACurrent
0362-1098Scandonest 3% PlainMepivacaine HydrochlorideSeptodont, Inc.ANDACurrent
0362-1098Scandonest 3% PlainMepivacaine HydrochlorideSeptodont, Inc.ANDACurrent
0362-1098Scandonest 3% PlainMepivacaine HydrochlorideSeptodont, Inc.ANDACurrent
0404-6730Mepivacaine HydrochlorideMepivacaine HydrochlorideHenry Schein Inc.ANDACurrent
0404-6730Mepivacaine HydrochlorideMepivacaine HydrochlorideHenry Schein Inc.ANDACurrent
0404-6730Mepivacaine HydrochlorideMepivacaine HydrochlorideHenry Schein Inc.ANDACurrent
0404-6730Mepivacaine HydrochlorideMepivacaine HydrochlorideHenry Schein Inc.ANDACurrent
0404-6730Mepivacaine HydrochlorideMepivacaine HydrochlorideHenry Schein Inc.ANDACurrent
31382-753CarbocaineMepivacaine hydrochlorideCaresteam Health, Inc.ANDACurrent
42756-1080IQ Dental MepivacaineMepivacaine HydrochlorideIQ DentalANDACurrent
42756-1080IQ Dental MepivacaineMepivacaine HydrochlorideIQ DentalANDACurrent
42756-1080IQ Dental MepivacaineMepivacaine HydrochlorideIQ DentalANDACurrent
43128-005MepivacaineMepivacaine HydrochlorideNDC, Inc.ANDACurrent
43128-005MepivacaineMepivacaine HydrochlorideNDC, Inc.ANDACurrent
43128-005MepivacaineMepivacaine HydrochlorideNDC, Inc.ANDACurrent
43305-1080Pearson MepivacaineMepivacaine HydrochloridePearson DentalANDACurrent
50227-1080MepivacaineMepivacaine HydrochloridePatterson Dental Supply, Inc.ANDACurrent
50227-1080MepivacaineMepivacaine HydrochloridePatterson Dental Supply, Inc.ANDACurrent
50227-1080MepivacaineMepivacaine HydrochloridePatterson Dental Supply, Inc.ANDACurrent
51004-0053MepivacaineMepivacaine HydrochlorideNovocol Pharmaceutical of Canada, Inc.ANDACurrent
51004-1098Scandonest PlainMepivacaine HydrochlorideNovocol Pharmaceutical of Canada, Inc.ANDACurrent
51004-2020IsocaineMepivacaine HydrochlorideNovocol Pharmaceutical of Canada, Inc.ANDACurrent
66312-441PolocaineMepivacaine HydrochlorideDentsply PharmaceuticalANDACurrent
66312-441PolocaineMepivacaine HydrochlorideDentsply PharmaceuticalANDACurrent
66312-441PolocaineMepivacaine HydrochlorideDentsply PharmaceuticalANDACurrent
66312-441PolocaineMepivacaine HydrochlorideDentsply PharmaceuticalANDACurrent
66467-9760MepivacaineMepivacaine HydrochlorideDarby Dental Supply, LLCANDACurrent
66467-9760MepivacaineMepivacaine HydrochlorideDarby Dental Supply, LLCANDACurrent
66467-9760MepivacaineMepivacaine HydrochlorideDarby Dental Supply, LLCANDACurrent
66975-406MepivacaineMepivacaine HydrochlorideBenco DentalANDACurrent
66975-406MepivacaineMepivacaine HydrochlorideBenco DentalANDACurrent
66975-406MepivacaineMepivacaine HydrochlorideBenco DentalANDACurrent
67239-0201MEPIVACAINE HYDROCHLORIDEMepivacaine HydrochlorideSafco Dental Supply Co.ANDACurrent
67239-0201MEPIVACAINE HYDROCHLORIDEMepivacaine HydrochlorideSafco Dental Supply Co.ANDACurrent
67239-0201MEPIVACAINE HYDROCHLORIDEMepivacaine HydrochlorideSafco Dental Supply Co.ANDACurrent
67239-0201MEPIVACAINE HYDROCHLORIDEMepivacaine HydrochlorideSafco Dental Supply Co.ANDACurrent