FDA Approved Products

Application #TypeSponsorNotesProduct #Drug NameFormStrengthActive IngredientApproval DateMarketing StatusReference Standard
021451NDADENTSPLY PHARM001ORAQIXGEL;PERIODONTAL2.5%;2.5%LIDOCAINE; PRILOCAINE2003-12-19PrescriptionYes
089517ANDADENTSPLY PHARM001POLOCAINE W/ LEVONORDEFRININJECTABLE;INJECTION0.05MG/ML;2%LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE1988-04-14DiscontinuedNo
088653ANDADENTSPLY PHARM001POLOCAINEINJECTABLE;INJECTION3%MEPIVACAINE HYDROCHLORIDE1984-08-21DiscontinuedNo
021384NDADENTSPLY PHARM001DURANESTINJECTABLE;INJECTION0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE1976-08-30DiscontinuedNo
021383NDADENTSPLY PHARM001CITANEST FORTE DENTALINJECTABLE;INJECTION0.005MG/ML;4%EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE1965-11-18PrescriptionYes
021382NDADENTSPLY PHARM001CITANEST PLAIN DENTALINJECTABLE;INJECTION4%PRILOCAINE HYDROCHLORIDE1965-11-18DiscontinuedNo
021380NDADENTSPLY PHARM001XYLOCAINE DENTALINJECTABLE;INJECTION2%LIDOCAINE HYDROCHLORIDE1948-11-19DiscontinuedNo
021381NDADENTSPLY PHARM001XYLOCAINE DENTAL WITH EPINEPHRINEINJECTABLE;INJECTION0.01MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**EPINEPHRINE; LIDOCAINE HYDROCHLORIDE1948-11-19DiscontinuedNo
002XYLOCAINE DENTAL WITH EPINEPHRINEINJECTABLE;INJECTION0.02MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**EPINEPHRINE; LIDOCAINE HYDROCHLORIDE1948-11-19DiscontinuedNo