FDA Approved Products

Application #	Type	Sponsor	Product #	Drug Name	Form	Strength	Active Ingredient	Approval Date	Marketing Status	Reference Standard
215955	ANDA	GE HEALTHCARE	001	REGADENOSON	SOLUTION;INTRAVENOUS	0.4MG/5ML (0.08MG/ML)	REGADENOSON	2024-08-05	Prescription	No
212155	NDA	GE HEALTHCARE	001	CERIANNA	SOLUTION;INTRAVENOUS	50ML (4-100mCi/ML)	FLUOROESTRADIOL F-18	2020-05-20	Prescription	Yes
210016	ANDA	GE HEALTHCARE	001	CLARISCAN	SOLUTION;INTRAVENOUS	3.769GM/10ML (376.9MG/ML)	GADOTERATE MEGLUMINE	2019-11-01	Prescription	No
			002	CLARISCAN	SOLUTION;INTRAVENOUS	5.6535GM/15ML (376.9MG/ML)	GADOTERATE MEGLUMINE	2019-11-01	Prescription	No
			003	CLARISCAN	SOLUTION;INTRAVENOUS	7.538GM/20ML (376.9MG/ML)	GADOTERATE MEGLUMINE	2019-11-01	Prescription	No
			004	CLARISCAN	SOLUTION;INTRAVENOUS	37.69GM/100ML (376.9MG/ML)	GADOTERATE MEGLUMINE	2019-11-01	Prescription	No
			005	CLARISCAN	SOLUTION;INTRAVENOUS	1.8845GM/5ML (376.9MG/ML)	GADOTERATE MEGLUMINE	2019-11-01	Prescription	No
203137	NDA	GE HEALTHCARE	001	VIZAMYL	INJECTABLE;INTRAVENOUS	40.5mCi/10ML (4.05mCi/ML)	FLUTEMETAMOL F-18	2013-10-25	Discontinued	No
203137	NDA	GE HEALTHCARE	002	VIZAMYL	INJECTABLE;INTRAVENOUS	121.5mCi/30ML (4.05mCi/ML)	FLUTEMETAMOL F-18	2013-10-25	Prescription	Yes
022290	NDA	GE HEALTHCARE	001	ADREVIEW	SOLUTION;INTRAVENOUS	10mCi/5ML (2mCi/ML)	IOBENGUANE SULFATE I-123	2008-09-19	Prescription	Yes
022066	NDA	GE HEALTHCARE	001	OMNISCAN	INJECTABLE;INJECTION	14.35GM/50ML (287MG/ML)	GADODIAMIDE	2007-09-05	Discontinued	No
022066	NDA	GE HEALTHCARE	002	OMNISCAN	INJECTABLE;INJECTION	28.7GM/100ML (287MG/ML)	GADODIAMIDE	2007-09-05	Discontinued	No
020899	NDA	GE HEALTHCARE	001	OPTISON	INJECTABLE;INJECTION	10MG/ML	ALBUMIN HUMAN	1997-12-31	Prescription	Yes
020808	NDA	GE HEALTHCARE	001	VISIPAQUE 270	INJECTABLE;INJECTION	55%	IODIXANOL	1997-08-29	Discontinued	No
020808	NDA	GE HEALTHCARE	002	VISIPAQUE 320	INJECTABLE;INJECTION	65.2%	IODIXANOL	1997-08-29	Prescription	No
020351	NDA	GE HEALTHCARE	001	VISIPAQUE 270	INJECTABLE;INJECTION	55%	IODIXANOL	1996-03-22	Prescription	Yes
020351	NDA	GE HEALTHCARE	002	VISIPAQUE 320	INJECTABLE;INJECTION	65.2%	IODIXANOL	1996-03-22	Prescription	Yes
020608	NDA	GE HEALTHCARE	001	OMNIPAQUE 240	SOLUTION;INJECTION, ORAL, RECTAL	51.8%	IOHEXOL	1995-10-24	Discontinued	No
			002	OMNIPAQUE 300	SOLUTION;INJECTION, ORAL, RECTAL	64.7%	IOHEXOL	1995-10-24	Prescription	No
			003	OMNIPAQUE 350	SOLUTION;INJECTION, ORAL	75.5%	IOHEXOL	1995-10-24	Prescription	No
020123	NDA	GE HEALTHCARE	001	OMNISCAN	INJECTABLE;INJECTION	287MG/ML	GADODIAMIDE	1993-01-08	Prescription	Yes
019862	NDA	GE HEALTHCARE	001	INDICLOR	INJECTABLE;INJECTION	2mCi/0.2ML	INDIUM IN-111 CHLORIDE	1992-12-29	Discontinued	No
019829	NDA	GE HEALTHCARE	001	CERETEC	INJECTABLE;INJECTION	N/A	TECHNETIUM TC-99M EXAMETAZIME KIT	1988-12-30	Prescription	Yes
018956	NDA	GE HEALTHCARE	009	OMNIPAQUE 12	SOLUTION;ORAL	2.6%	IOHEXOL	1985-12-26	Prescription	Yes
			005	OMNIPAQUE 140	INJECTABLE;INJECTION	30.2%	IOHEXOL	1985-12-26	Prescription	Yes
			001	OMNIPAQUE 180	SOLUTION;INJECTION, ORAL, RECTAL	38.8%	IOHEXOL	1985-12-26	Prescription	Yes
			006	OMNIPAQUE 210	INJECTABLE;INJECTION	45.3%	IOHEXOL	1985-12-26	Discontinued	No
			002	OMNIPAQUE 240	SOLUTION;INJECTION, ORAL, RECTAL	51.8%	IOHEXOL	1985-12-26	Prescription	Yes
			003	OMNIPAQUE 300	SOLUTION;INJECTION, ORAL, RECTAL	64.7%	IOHEXOL	1985-12-26	Prescription	Yes
			004	OMNIPAQUE 350	SOLUTION;INJECTION, ORAL	75.5%	IOHEXOL	1985-12-26	Prescription	Yes
			007	OMNIPAQUE 70	SOLUTION;URETHRAL	15.1%	IOHEXOL	1985-12-26	Discontinued	No
			008	OMNIPAQUE 9	SOLUTION;ORAL	1.9%	IOHEXOL	1985-12-26	Prescription	Yes
019044	NDA	GE HEALTHCARE	001	INDIUM IN 111 OXYQUINOLINE	INJECTABLE;INJECTION	1mCi/ML	INDIUM IN-111 OXYQUINOLINE	1985-12-24	Prescription	Yes
018289	NDA	GE HEALTHCARE	001	NEPHROFLOW	INJECTABLE;INJECTION	1mCi/ML	IODOHIPPURATE SODIUM I-123	1984-12-28	Discontinued	No
018335	NDA	GE HEALTHCARE	001	AMERSCAN MDP KIT	INJECTABLE;INJECTION	N/A	TECHNETIUM TC-99M MEDRONATE KIT	1982-08-05	Discontinued	No
017944	NDA	GE HEALTHCARE	001	MPI DMSA KIDNEY REAGENT	INJECTABLE;INJECTION	N/A Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TECHNETIUM TC-99M SUCCIMER KIT	1982-05-18	Discontinued	No
017707	NDA	GE HEALTHCARE	001	MPI INDIUM DTPA IN 111	INJECTABLE;INTRATHECAL	1mCi/ML	INDIUM IN-111 PENTETATE DISODIUM	1982-02-18	Prescription	Yes
018110	NDA	GE HEALTHCARE	002	THALLOUS CHLORIDE TL 201	INJECTABLE;INJECTION	1mCi/ML	THALLOUS CHLORIDE TL-201	1982-02-01	Discontinued	No
086505	ANDA	GE HEALTHCARE	001	HYPAQUE-76	INJECTABLE;INJECTION	66%;10%	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	1980-07-02	Discontinued	No
018088	NDA	GE HEALTHCARE	001	MPI KRYPTON 81M GENERATOR	GAS;INHALATION	N/A	KRYPTON, KR-81M	1980-06-12	Discontinued	No
018141	NDA	GE HEALTHCARE	001	TECHNETIUM TC 99M MPI MDP	INJECTABLE;INJECTION	N/A	TECHNETIUM TC-99M MEDRONATE KIT	1979-06-26	Discontinued	No
018141	NDA	GE HEALTHCARE	002	TECHNETIUM TC 99M MPI MDP	INJECTABLE;INJECTION	N/A	TECHNETIUM TC-99M MEDRONATE KIT	1979-06-26	Discontinued	No
017982	NDA	GE HEALTHCARE	001	AMIPAQUE	INJECTABLE;INJECTION	3.75GM/VIAL	METRIZAMIDE	1978-08-23	Discontinued	No
			002	AMIPAQUE	INJECTABLE;INJECTION	6.75GM/VIAL	METRIZAMIDE	1978-08-23	Discontinued	No
			003	AMIPAQUE	INJECTABLE;INJECTION	2.5GM/VIAL	METRIZAMIDE	1978-08-23	Discontinued	No
			004	AMIPAQUE	INJECTABLE;INJECTION	13.5GM/VIAL	METRIZAMIDE	1978-08-23	Discontinued	No
017655	NDA	GE HEALTHCARE	001	NEOSCAN	INJECTABLE;INJECTION	2mCi/ML	GALLIUM CITRATE GA-67	1978-05-01	Discontinued	No
017700	NDA	GE HEALTHCARE	001	GALLIUM CITRATE GA 67	INJECTABLE;INJECTION	1mCi/ML	GALLIUM CITRATE GA-67	1977-12-16	Discontinued	No
017667	NDA	GE HEALTHCARE	001	MPI STANNOUS DIPHOSPHONATE	INJECTABLE;INJECTION	N/A	TECHNETIUM TC-99M ETIDRONATE KIT	1977-04-01	Discontinued	No
017653	NDA	GE HEALTHCARE	001	CINTICHEM TECHNETIUM 99M HEDSPA	INJECTABLE;INJECTION	N/A	TECHNETIUM TC-99M ETIDRONATE KIT	1976-11-18	Discontinued	No
017784	NDA	GE HEALTHCARE	001	TECHNETIUM TC 99M TSC	SOLUTION;INJECTION, ORAL	N/A	TECHNETIUM TC-99M SULFUR COLLOID KIT	1976-11-18	Discontinued	No
017687	NDA	GE HEALTHCARE	002	XENON XE 133	GAS;INHALATION	10mCi/VIAL	XENON XE-133	1976-11-16	Discontinued	No
			003	XENON XE 133	GAS;INHALATION	20mCi/VIAL	XENON XE-133	1976-11-16	Discontinued	No
			001	XENON XE 133-V.S.S.	GAS;INHALATION	10mCi/VIAL	XENON XE-133	1976-11-16	Discontinued	No
017693	NDA	GE HEALTHCARE	001	DRYTEC	SOLUTION;INTRAVENOUS, ORAL	830-16600mCi/GENERATOR	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR	1976-11-15	Discontinued	No
017693	NDA	GE HEALTHCARE	002	DRYTEC	SOLUTION;INTRAVENOUS, ORAL	68-2703mCi/GENERATOR	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR	1976-11-15	Discontinued	No
017257	NDA	GE HEALTHCARE	001	SELENOMETHIONINE SE 75	INJECTABLE;INJECTION	250uCi/ML	SELENOMETHIONINE SE-75	1976-11-09	Discontinued	No
017256	NDA	GE HEALTHCARE	001	XENON XE 133	INJECTABLE;INJECTION	1.3-1.7 CI/AMP	XENON XE-133	1976-11-09	Discontinued	No
017256	NDA	GE HEALTHCARE	002	XENON XE 133	GAS;INHALATION	1 CI/AMP	XENON XE-133	1976-11-09	Discontinued	No
017664	NDA	GE HEALTHCARE	001	SODIUM POLYPHOSPHATE-TIN KIT	INJECTABLE;INJECTION	N/A	TECHNETIUM TC-99M POLYPHOSPHATE KIT	1976-10-28	Discontinued	No
017562	NDA	GE HEALTHCARE	001	TECHNETIUM TC 99M DIPHOSPHONATE-TIN KIT	INJECTABLE;INJECTION	N/A	TECHNETIUM TC-99M ETIDRONATE KIT	1976-08-05	Discontinued	No
017255	NDA	GE HEALTHCARE	001	MPI DTPA KIT - CHELATE	INJECTABLE;INJECTION	N/A	TECHNETIUM TC-99M PENTETATE KIT	1976-04-15	Discontinued	No
017630	NDA	GE HEALTHCARE	001	SODIUM IODIDE I 123	CAPSULE;ORAL	100uCi	SODIUM IODIDE I-123	1976-03-24	Discontinued	No
			002	SODIUM IODIDE I 123	SOLUTION;ORAL	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SODIUM IODIDE I-123	1976-03-24	Discontinued	No
			003	SODIUM IODIDE I 123	CAPSULE;ORAL	200uCi	SODIUM IODIDE I-123	1976-03-24	Discontinued	No
017456	NDA	GE HEALTHCARE	001	TECHNETIUM TC 99M SULFUR COLLOID	SOLUTION;INJECTION, ORAL	4mCi/ML	TECHNETIUM TC-99M SULFUR COLLOID	1974-09-24	Discontinued	No
017471	NDA	GE HEALTHCARE	001	SODIUM PERTECHNETATE TC 99M	SOLUTION;INJECTION, ORAL	2-100mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TECHNETIUM TC-99M SODIUM PERTECHNETATE	1974-07-18	Discontinued	No
017406	NDA	GE HEALTHCARE	001	DICOPAC KIT	N/A;N/A	N/A;N/A;N/A	CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; CYANOCOBALAMIN CO-58	1974-06-10	Discontinued	No
017506	NDA	GE HEALTHCARE	001	ISOPAQUE 280	INJECTABLE;INJECTION	0.35MG/ML;140.1MG/ML;461.8MG/ML	CALCIUM; MEGLUMINE; METRIZOIC ACID	1974-04-30	Discontinued	No
017264	NDA	GE HEALTHCARE	002	TECHNETIUM TC-99M PENTETATE KIT	INJECTABLE;INJECTION	N/A	TECHNETIUM TC-99M PENTETATE KIT	1974-02-14	Discontinued	No
016847	NDA	GE HEALTHCARE	001	ISOPAQUE 440	INJECTABLE;INJECTION	0.78MG/ML;75.9MG/ML;0.15MG/ML;16.6MG/ML	CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM	1973-11-17	Discontinued	No
017042	NDA	GE HEALTHCARE	001	FLUORINE F-18	INJECTABLE;INTRAVENOUS	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SODIUM FLUORIDE F-18	1972-02-24	Discontinued	No
013731	NDA	GE HEALTHCARE	001	BILOPAQUE	CAPSULE;ORAL	750MG	TYROPANOATE SODIUM	1969-10-24	Discontinued	No
016403	NDA	GE HEALTHCARE	001	HYPAQUE	INJECTABLE;INJECTION	60%	DIATRIZOATE MEGLUMINE	1969-08-21	Discontinued	No
			002	HYPAQUE	INJECTABLE;INJECTION	30%	DIATRIZOATE MEGLUMINE	1969-08-21	Discontinued	No
			003	HYPAQUE-CYSTO	SOLUTION;URETHRAL	30%	DIATRIZOATE MEGLUMINE	1969-08-21	Discontinued	No
011386	NDA	GE HEALTHCARE	001	HYPAQUE	FOR SOLUTION;ORAL, RECTAL	100%	DIATRIZOATE SODIUM	1956-03-26	Discontinued	No
011386	NDA	GE HEALTHCARE	003	HYPAQUE	SOLUTION;ORAL, RECTAL	40%	DIATRIZOATE SODIUM	1956-03-26	Discontinued	No
010220	NDA	GE HEALTHCARE	003	HYPAQUE-M,75%	INJECTABLE;INJECTION	50%;25%	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	1955-11-09	Discontinued	No
010220	NDA	GE HEALTHCARE	002	HYPAQUE-M,90%	INJECTABLE;INJECTION	60%;30%	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	1955-11-09	Discontinued	No
009561	NDA	GE HEALTHCARE	001	HYPAQUE	INJECTABLE;INJECTION	50%	DIATRIZOATE SODIUM	1954-11-26	Discontinued	No
			003	HYPAQUE	INJECTABLE;INJECTION	25%	DIATRIZOATE SODIUM	1954-11-26	Discontinued	No
			002	HYPAQUE SODIUM 20%	SOLUTION;URETERAL	20%	DIATRIZOATE SODIUM	1954-11-26	Discontinued	No
008032	NDA	GE HEALTHCARE	001	TELEPAQUE	TABLET;ORAL	500MG	IOPANOIC ACID	1951-07-16	Discontinued	No