Epinephrine / Prilocaine Prefilled Syringe

Brand(s)
Citanest Forte
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Dentsply Pharmaceutical (2014-05-19)
Oldest Current Product
1965-11-18
License(s)
NDA, ANDA
RxNORM
PREFILLED SYRINGE\EPINEPHRINE:PRILOCAINE
FDAOB
INJECTION\INJECTION\EPINEPHRINE BITARTRATE: PRILOCAINE HYDROCHLORIDE\rdfq
INJECTION\INJECTION\PRILOCAINE HYDROCHLORIDE\rdfq
SPL Active
DENTAL\INJECTION, SOLUTION\EPINEPHRINE BITARTRATE: PRILOCAINE HYDROCHLORIDE
SUBCUTANEOUS\INJECTION, SOLUTION\EPINEPHRINE BITARTRATE: PRILOCAINE HYDROCHLORIDE
SPL Moiety
DENTAL\INJECTION, SOLUTION\EPINEPHRINE: PRILOCAINE
SUBCUTANEOUS\INJECTION, SOLUTION\EPINEPHRINE: PRILOCAINE

product(s) by strength(s)

1.8 ml epinephrine 0.005 mg/ml / prilocaine hydrochloride 40 mg/ml prefilled syringe

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003629013ANDASeptodont Inc.2011-09-10EPINEPHRINE BITARTRATE, PRILOCAINE HYDROCHLORIDESUBCUTANEOUSINJECTION, SOLUTIONANDA078959b374a5f1-ef37-402d-b011-ca8d20689f02

1.7 ml epinephrine 0.005 mg/ml / prilocaine hydrochloride 40 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1663120540Citanest ForteNDADentsply Pharmaceutical1965-11-18EPINEPHRINE BITARTRATE, PRILOCAINE HYDROCHLORIDEDENTALINJECTION, SOLUTIONNDA021383a654df2a-68bc-43c5-bd97-ad43f8679dc0

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA078959PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATESEPTODONT INC2011-08-30ANDA078959_001
2NDA014763CITANESTTrueASTRAZENECA LPNDA014763_003, NDA014763_004, NDA014763_005, NDA014763_007, NDA014763_008Prilocaine Prefilled Syringe
3NDA021383CITANEST FORTE DENTALDENTSPLY PHARMACEUTICAL INCNDA021383_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA078959_001RXEPINEPHRINE BITARTRATE (0.005MG/ML), PRILOCAINE HYDROCHLORIDE (4%)INJECTIONFalseAP2011-08-30PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
2NDA014763_003discontinuedPRILOCAINE HYDROCHLORIDE (3%)INJECTIONFalseCITANEST
3NDA014763_004discontinuedPRILOCAINE HYDROCHLORIDE (1%)INJECTIONFalseCITANEST
4NDA014763_005discontinuedPRILOCAINE HYDROCHLORIDE (2%)INJECTIONFalseCITANEST
5NDA014763_007discontinuedPRILOCAINE HYDROCHLORIDE (4%)INJECTIONFalseCITANEST
6NDA014763_008discontinuedEPINEPHRINE BITARTRATE (0.005MG/ML), PRILOCAINE HYDROCHLORIDE (4%)INJECTIONFalseCITANEST
7NDA021383_001RXEPINEPHRINE BITARTRATE (0.005MG/ML), PRILOCAINE HYDROCHLORIDE (4%)INJECTIONTrueAPCITANEST FORTE DENTAL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a654df2a-68bc-43c5-bd97-ad43f8679dc0 (view SPL)Citanest Forte(prilocaine and epinephrine bitartrate injection, solution)prescriptionHuman PrescriptionDentsply PharmaceuticalMANUFACTURE2014-05-197663120540
2b374a5f1-ef37-402d-b011-ca8d20689f02 (view SPL)Prilocaine HCl 4% with Epinephrine 1:200,000 InjectionprescriptionHuman PrescriptionSeptodont Inc.MANUFACTURE2011-09-011003629013

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