Prilocaine Prefilled Syringe

Brand(s)
Citanest
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Septodont Inc. (2010-10-08)
Oldest Current Product
1965-11-18
License(s)
ANDA
RxNORM
PREFILLED SYRINGE\PRILOCAINE
FDAOB
INJECTION\INJECTION\EPINEPHRINE BITARTRATE: PRILOCAINE HYDROCHLORIDE\rdfq
INJECTION\INJECTION\PRILOCAINE HYDROCHLORIDE\rdfq
SPL Active
DENTAL\INJECTION, SOLUTION\PRILOCAINE HYDROCHLORIDE
SUBCUTANEOUS\INJECTION, SOLUTION\PRILOCAINE HYDROCHLORIDE
SPL Moiety
DENTAL\INJECTION, SOLUTION\PRILOCAINE
SUBCUTANEOUS\INJECTION, SOLUTION\PRILOCAINE

product(s) by strength(s)

1.8 ml prilocaine hydrochloride 40 mg/ml prefilled syringe

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003629014ANDASeptodont Inc.2011-01-01PRILOCAINE HYDROCHLORIDESUBCUTANEOUSINJECTION, SOLUTIONANDA079235ca454f96-2e2d-46ed-95af-c741726773de
2663120630CitanestANDADentsply Pharmaceutical1965-11-18PRILOCAINE HYDROCHLORIDEDENTALINJECTION, SOLUTIONANDA079235db23a56f-1e41-4843-9220-1b2e3059db41

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA079235PRILOCAINE HYDROCHLORIDESEPTODONT INC2010-09-29ANDA079235_001
2NDA014763CITANESTTrueASTRAZENECA LPNDA014763_003, NDA014763_004, NDA014763_005, NDA014763_007, NDA014763_008Epinephrine / Prilocaine Prefilled Syringe
3NDA021382CITANEST PLAIN DENTALTrueDENTSPLY PHARMACEUTICAL INCNDA021382_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA079235_001RXPRILOCAINE HYDROCHLORIDE (4%)INJECTIONTrue2010-09-29PRILOCAINE HYDROCHLORIDE
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
7NDA021382_001discontinuedPRILOCAINE HYDROCHLORIDE (4%)INJECTIONFalseCITANEST PLAIN DENTAL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1ca454f96-2e2d-46ed-95af-c741726773de (view SPL)Prilocaine Hydrochloride Injection, USP, 4%prescriptionHuman PrescriptionSeptodont Inc.MANUFACTURE2010-10-081003629014
2db23a56f-1e41-4843-9220-1b2e3059db41 (view SPL)4% Citanest Plain DentalPrilocaine Hydrochloride Injection, USPprescriptionHuman PrescriptionDentsply PharmaceuticalMANUFACTURE2014-05-204663120630

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