Levonordefrin / Mepivacaine Cartridge

Brand(s)
Carbocaine with NeoCobefrin, Scandonest L
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novocol Pharmaceutical Of Canada, Inc. (2013-06-27)
Oldest Current Product
2011-01-01
License(s)
ANDA
RxNORM
CARTRIDGE\LEVONORDEFRIN:MEPIVACAINE
FDAOB
INJECTION\INJECTION\LEVONORDEFRIN: MEPIVACAINE HYDROCHLORIDE\rdfq
INJECTION\INJECTION\MEPIVACAINE HYDROCHLORIDE\rdfq
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\LEVONORDEFRIN: MEPIVACAINE HYDROCHLORIDE
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\LEVONORDEFRIN: MEPIVACAINE

product(s) by strength(s)

1.7 ml levonordefrin 0.05 mg/ml / mepivacaine hydrochloride 20 mg/ml cartridge

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1313820931Carbocaine with NeoCobefrinANDACarestream Health, Inc.2011-01-01LEVONORDEFRIN, MEPIVACAINE HYDROCHLORIDESUBCUTANEOUSINJECTION, SOLUTIONANDA088388f00557a9-ec79-4c54-9d06-c71d2a8aff2c
2502271090ANDAPatterson Dental2011-01-01LEVONORDEFRIN, MEPIVACAINE HYDROCHLORIDESUBCUTANEOUSINJECTION, SOLUTIONANDA088388e8a3df4b-e918-4813-af3e-3c95f2c54250
3510041097Scandonest LANDANovocol Pharmaceutical Of Canada, Inc.2013-06-27LEVONORDEFRIN, MEPIVACAINE HYDROCHLORIDESUBCUTANEOUSINJECTION, SOLUTIONANDA0883885852a2ed-adab-424c-8d68-ba9d6a628ddb
4664679790ANDADarby Dental Supply, Llc2011-01-14LEVONORDEFRIN, MEPIVACAINE HYDROCHLORIDESUBCUTANEOUSINJECTION, SOLUTIONANDA088388ec53613d-1046-4319-b3e0-53be284a6520
5669750416ANDABenco Dental2011-01-01LEVONORDEFRIN, MEPIVACAINE HYDROCHLORIDESUBCUTANEOUSINJECTION, SOLUTIONANDA088388c9a5a849-d010-4637-a66a-c26176401fbd

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA084697ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRINTrueNOVOCOL PHARMACEUTICAL INCANDA084697_001
2ANDA084850MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRINTrueGRAHAM CHEMICAL CO1983-10-21ANDA084850_002
3ANDA085010ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRINTrueSOLVAY PHARMACEUTICALSANDA085010_001
4ANDA088388SCANDONEST LDEPROCO INC1984-10-10ANDA088388_001
5ANDA089517POLOCAINE W/ LEVONORDEFRINTrueDENTSPLY PHARMACEUTICAL1988-04-14ANDA089517_001
6NDA012125CARBOCAINETrueEASTMAN KODAK CONDA012125_002, NDA012125_003Mepivacaine Cartridge
Mepivacaine Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA084697_001discontinuedLEVONORDEFRIN (0.05MG/ML), MEPIVACAINE HYDROCHLORIDE (2%)INJECTIONFalseISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN
2ANDA084850_002discontinuedLEVONORDEFRIN (0.05MG/ML), MEPIVACAINE HYDROCHLORIDE (2%)INJECTIONFalse1983-10-21MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN
3ANDA085010_001discontinuedLEVONORDEFRIN (0.05MG/ML), MEPIVACAINE HYDROCHLORIDE (2%)INJECTIONFalseARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN
4ANDA088388_001RXLEVONORDEFRIN (0.05MG/ML), MEPIVACAINE HYDROCHLORIDE (2%)INJECTIONTrue1984-10-10SCANDONEST L
5ANDA089517_001discontinuedLEVONORDEFRIN (0.05MG/ML), MEPIVACAINE HYDROCHLORIDE (2%)INJECTIONFalse1988-04-14POLOCAINE W/ LEVONORDEFRIN
6NDA012125_002discontinuedMEPIVACAINE HYDROCHLORIDE (2%), LEVONORDEFRIN (0.05MG/ML)INJECTIONFalseCARBOCAINE
7NDA012125_003discontinuedMEPIVACAINE HYDROCHLORIDE (3%)INJECTIONFalseCARBOCAINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
15852a2ed-adab-424c-8d68-ba9d6a628ddb (view SPL)Scandonest 3% Plain(Mepivacaine Hydrochloride Injection, USP) Scandonest 2% L (with Levonordefrin 1:20,000)(Mepivacaine Hydrochloride and Levonordefrin Injection, USP)prescriptionHuman PrescriptionNovocol Pharmaceutical Of Canada, Inc.manufacture2013-06-271510041097
2c9a5a849-d010-4637-a66a-c26176401fbd (view SPL)Mepivacaine HCl 3% (Mepivacaine Hydrochloride Injection, USP) Mepivacaine HCl 2% (with Levonordefrin 1:20,000) (Mepivacaine Hydrochloride and Levonordefrin Injection, USP)prescriptionHuman PrescriptionBenco DentalMANUFACTURE2012-05-241669750416, 669750406Mepivacaine Cartridge
3e8a3df4b-e918-4813-af3e-3c95f2c54250 (view SPL)Mepivacaine HCl 3% (Mepivacaine Hydrochloride Injection, USP) Mepivacaine HCl 2% (with Levonordefrin 1:20,000) (Mepivacaine Hydrochloride and Levonordefrin Injection, USP)prescriptionHuman PrescriptionPatterson DentalMANUFACTURE2012-05-111502271090, 502271080Mepivacaine Cartridge
4ec53613d-1046-4319-b3e0-53be284a6520 (view SPL)Mepivacaine HCl 3% (Mepivacaine Hydrochloride Injection, USP) Mepivacaine HCl 2% (with Levonordefrin 1:20,000) (Mepivacaine Hydrochloride and Levonordefrin Injection, USP)prescriptionHuman PrescriptionDarby Dental Supply, Llc2011-08-231664679790
5f00557a9-ec79-4c54-9d06-c71d2a8aff2c (view SPL)Carbocaine 3% injection (mepivacaine hydrochloride injection, USP) Carbocaine 2% with Neo-Cobefrin 1:20,000 injection (mepivacaine hydrochloride and levonordefrin injection, USP)prescriptionHuman PrescriptionCarestream Health, Inc.MANUFACTURE2012-05-241313820931, 313820753Mepivacaine Cartridge

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII