FDA.reportPublic FDA data

Application 022466

Type
NDA
Sponsor
PIERREL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORABLOCARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML)YesNo
002ORABLOCARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45146-110Orablocarticaine hydrochloride and epinephrine bitartratePierrel S.p.A.NDACurrent
45146-110Orablocarticaine hydrochloride and epinephrine bitartratePierrel S.p.A.NDACurrent
45146-120Orablocarticaine hydrochloride and epinephrine bitartratePierrel S.p.A.NDACurrent
45146-120Orablocarticaine hydrochloride and epinephrine bitartratePierrel S.p.A.NDACurrent
67239-0209Articaine HCl and Epinephrinearticaine hydrochloride and epinephrine bitartrateSafco Dental Supply Co.NDACurrent
67239-0209Articaine HCl and Epinephrinearticaine hydrochloride and epinephrine bitartrateSafco Dental Supply Co.NDACurrent
67239-0210Articaine HCl and Epinephrinearticaine hydrochloride and epinephrine bitartrateSafco Dental Supply Co.NDACurrent
67239-0210Articaine HCl and Epinephrinearticaine hydrochloride and epinephrine bitartrateSafco Dental Supply Co.NDACurrent
72304-015Articaine Hydrochloride and EpinephrineARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATEMidway Dental Supply, LLCNDACurrent
72304-015Articaine Hydrochloride and EpinephrineARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATEMidway Dental Supply, LLCNDACurrent
72304-015Articaine Hydrochloride and EpinephrineARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATEMidway Dental Supply, LLCNDACurrent
72304-016Articaine Hydrochloride and EpinephrineARTICAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEMidway Dental Supply, LLCNDACurrent
72304-016Articaine Hydrochloride and EpinephrineARTICAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEMidway Dental Supply, LLCNDACurrent
72304-016Articaine Hydrochloride and EpinephrineARTICAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEMidway Dental Supply, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82756SUPPL 2025-07-08
82729SUPPL 2025-07-03
56401SUPPL2018-11-09
56275SUPPL2018-11-05
24316ORIG2011-02-17
7433SUPPL2011-01-25
38742SUPPL2011-01-24
42532ORIG2010-12-01
7432ORIG2010-03-04
17616ORIG2010-03-02