FDA.reportPublic FDA data

Application 021451

Type
NDA
Sponsor
DENTSPLY PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORAQIXLIDOCAINE; PRILOCAINEGEL;PERIODONTAL2.5%;2.5%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66312-110Oraqixlidocaine and prilocaineDENTSPLY PharmaceuticalNDACurrent
66312-110Oraqixlidocaine and prilocaineDentsply PharmaceuticalNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56395SUPPL2018-11-09
56271SUPPL2018-11-05
27834SUPPL2012-08-10
36975SUPPL2012-08-09
27833SUPPL2010-09-29
36974SUPPL2010-09-27
5430SUPPL2010-04-20
36973SUPPL2010-04-19
42174ORIG2006-09-07
15512ORIG2003-12-29
5429ORIG2003-12-23