FDA Approved Products

Application #TypeSponsorNotesProduct #Drug NameFormStrengthActive IngredientApproval DateMarketing StatusReference Standard
021711NDALANTHEUS MEDCL001ABLAVARSOLUTION;INTRAVENOUS2440MG/10ML (244MG/ML)GADOFOSVESET TRISODIUM2008-12-22DiscontinuedNo
002ABLAVARSOLUTION;INTRAVENOUS3660MG/15ML (244MG/ML)GADOFOSVESET TRISODIUM2008-12-22DiscontinuedNo
021064NDALANTHEUS MEDCL001DEFINITYINJECTABLE;INTRAVENOUS13.04MG/2ML (6.52MG/ML)PERFLUTREN2001-07-31PrescriptionYes
002DEFINITY RTINJECTABLE;INTRAVENOUS13.04MG/2ML (6.52MG/ML)PERFLUTREN2001-07-31PrescriptionYes
020570NDALANTHEUS MEDICAL001QUADRAMETINJECTABLE;INJECTION50mCi/MLSAMARIUM SM-153 LEXIDRONAM PENTASODIUM1997-03-28DiscontinuedNo
020256NDALANTHEUS MEDCL001NEUROLITEINJECTABLE;INJECTIONN/ATECHNETIUM TC-99M BICISATE KIT1994-11-23PrescriptionYes
019785NDALANTHEUS MEDCL001CARDIOLITEINJECTABLE;INJECTIONN/ATECHNETIUM TC-99M SESTAMIBI KIT1990-12-21PrescriptionYes
003MIRALUMAINJECTABLE;INJECTIONN/ATECHNETIUM TC-99M SESTAMIBI KIT1990-12-21DiscontinuedNo
017806NDALANTHEUS MEDCL001THALLOUS CHLORIDE TL 201INJECTABLE;INJECTION1mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**THALLOUS CHLORIDE TL-2011977-12-16DiscontinuedNo
002THALLOUS CHLORIDE TL 201INJECTABLE;INTRAVENOUS2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**THALLOUS CHLORIDE TL-2011977-12-16DiscontinuedNo
017771NDALANTHEUS MEDCL001TECHNELITESOLUTION;INTRAVENOUS0.0083-2.7 CI/GENERATORTECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR1976-11-16DiscontinuedNo
002TECHNELITESOLUTION;INTRAVENOUS1-20 CI/GENERATORTECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR1976-11-16PrescriptionYes
017478NDALANTHEUS MEDCL001GALLIUM CITRATE GA 67INJECTABLE;INJECTION2mCi/MLGALLIUM CITRATE GA-671976-05-17DiscontinuedNo
017283NDALANTHEUS MEDCL001XENON XE 133INJECTABLE;INJECTION6.3mCi/MLXENON XE-1331974-10-11DiscontinuedNo
017284NDALANTHEUS MEDCL001XENON XE 133GAS;INHALATION10mCi/VIALXENON XE-1331974-10-10PrescriptionNo
002XENON XE 133GAS;INHALATION20mCi/VIALXENON XE-1331974-10-10PrescriptionNo