FDA Approved Products

Application #	Type	Sponsor	Product #	Drug Name	Form	Strength	Active Ingredient	Approval Date	Marketing Status	Reference Standard
020345	ANDA	ICU MEDICAL INC	001	AMINOSYN-HF 8%	INJECTABLE;INJECTION	8% (8GM/100ML)	AMINO ACIDS	1996-04-04	Discontinued	No
019916	NDA	ICU MEDICAL INC	001	MORPHINE SULFATE	INJECTABLE;INJECTION	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	MORPHINE SULFATE	1992-10-30	Discontinued	No
019916	NDA	ICU MEDICAL INC	002	MORPHINE SULFATE	INJECTABLE;INJECTION	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	MORPHINE SULFATE	1992-10-30	Discontinued	No
019917	NDA	ICU MEDICAL INC	001	MORPHINE SULFATE	INJECTABLE;INJECTION	0.5MG/ML	MORPHINE SULFATE	1992-10-30	Discontinued	No
019894	NDA	ICU MEDICAL INC	001	DEXTROSE 50% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	50GM/100ML	DEXTROSE	1989-12-26	Discontinued	No
019438	NDA	ICU MEDICAL INC	005	AMINOSYN II 10%	INJECTABLE;INJECTION	10% (10GM/100ML)	AMINO ACIDS	1986-04-03	Discontinued	No
			001	AMINOSYN II 3.5%	INJECTABLE;INJECTION	3.5% (3.5GM/100ML)	AMINO ACIDS	1986-04-03	Discontinued	No
			002	AMINOSYN II 5%	INJECTABLE;INJECTION	5% (5GM/100ML)	AMINO ACIDS	1986-04-03	Discontinued	No
			003	AMINOSYN II 7%	INJECTABLE;INJECTION	7% (7GM/100ML)	AMINO ACIDS	1986-04-03	Discontinued	No
			004	AMINOSYN II 8.5%	INJECTABLE;INJECTION	8.5% (8.5GM/100ML)	AMINO ACIDS	1986-04-03	Discontinued	No
019437	NDA	ICU MEDICAL INC	004	AMINOSYN II 10% W/ ELECTROLYTES	INJECTABLE;INJECTION	10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE	1986-04-03	Discontinued	No
			007	AMINOSYN II 3.5% M	INJECTABLE;INJECTION	3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	1986-04-03	Discontinued	No
			006	AMINOSYN II 7% W/ ELECTROLYTES	INJECTABLE;INJECTION	7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE	1986-04-03	Discontinued	No
			005	AMINOSYN II 8.5% W/ ELECTROLYTES	INJECTABLE;INJECTION	8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE	1986-04-03	Discontinued	No
			008	AMINOSYN II 8.5% W/ELECTROLYTES	INJECTABLE;INJECTION	8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100ML	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC	1986-04-03	Discontinued	No
018876	NDA	ICU MEDICAL INC	001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	5GM/100ML;74.5MG/100ML;300MG/100ML	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	1986-01-17	Discontinued	No
			006	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	5GM/100ML;149MG/100ML;300MG/100ML	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	1986-01-17	Discontinued	No
			007	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	5GM/100ML;224MG/100ML;300MG/100ML	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	1986-01-17	Discontinued	No
			008	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	5GM/100ML;298MG/100ML;300MG/100ML	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	1986-01-17	Discontinued	No
			002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	5GM/100ML;149MG/100ML;300MG/100ML	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	1986-01-17	Discontinued	No
			003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	5GM/100ML;224MG/100ML;300MG/100ML	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	1986-01-17	Discontinued	No
			004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	5GM/100ML;298MG/100ML;300MG/100ML	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	1986-01-17	Discontinued	No
			005	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	5GM/100ML;74.5MG/100ML;300MG/100ML	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	1986-01-17	Discontinued	No
			009	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	5GM/100ML;149MG/100ML;300MG/100ML	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	1986-01-17	Discontinued	No
019374	NDA	ICU MEDICAL INC	001	AMINOSYN-HBC 7%	INJECTABLE;INJECTION	7% (7GM/100ML)	AMINO ACIDS	1985-07-12	Discontinued	No
088432	ANDA	ICU MEDICAL INC	001	MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE	INJECTABLE;INJECTION	10MG/ML	MEPERIDINE HYDROCHLORIDE	1984-08-16	Discontinued	No
019222	NDA	ICU MEDICAL INC	001	DEXTROSE 5% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	50MG/ML	DEXTROSE	1984-07-13	Discontinued	No
019217	NDA	ICU MEDICAL INC	002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SOLUTION;INJECTION	45MG/5ML (9MG/ML)	SODIUM CHLORIDE	1984-07-13	Discontinued	No
			003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SOLUTION;INJECTION	90MG/10ML (9MG/ML)	SODIUM CHLORIDE	1984-07-13	Discontinued	No
			004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SOLUTION;INJECTION	360MG/40ML (9MG/ML)	SODIUM CHLORIDE	1984-07-13	Discontinued	No
			001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	SOLUTION;INJECTION	90MG/10ML (9MG/ML)	SODIUM CHLORIDE	1984-07-13	Discontinued	No
018429	NDA	ICU MEDICAL INC	001	AMINOSYN-RF 5.2%	INJECTABLE;INJECTION	5.2% (5.2GM/100ML)	AMINO ACIDS	1980-11-28	Discontinued	No
017789	NDA	ICU MEDICAL INC	004	AMINOSYN 3.5%	INJECTABLE;INJECTION	3.5% (3.5GM/100ML)	AMINO ACIDS	1976-05-14	Discontinued	No
			003	AMINOSYN 3.5% M	INJECTABLE;INJECTION	3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/100ML	AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE	1976-05-14	Discontinued	No
			005	AMINOSYN 3.5% M	INJECTABLE;INJECTION	3.5%;21MG/100ML;128MG/100ML;234MG/100ML	AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE	1976-05-14	Discontinued	No
			002	AMINOSYN 7% W/ ELECTROLYTES	INJECTABLE;INJECTION	7%;102MG/100ML;522MG/100ML;410MG/100ML	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE	1976-05-14	Discontinued	No
017673	NDA	ICU MEDICAL INC	003	AMINOSYN 10%	INJECTABLE;INJECTION	10% (10GM/100ML)	AMINO ACIDS	1975-12-03	Discontinued	No
			008	AMINOSYN 10% (PH6)	INJECTABLE;INJECTION	10% (10GM/100ML)	AMINO ACIDS	1975-12-03	Discontinued	No
			001	AMINOSYN 5%	INJECTABLE;INJECTION	5% (5GM/100ML)	AMINO ACIDS	1975-12-03	Discontinued	No
			002	AMINOSYN 7%	INJECTABLE;INJECTION	7% (7GM/100ML)	AMINO ACIDS	1975-12-03	Discontinued	No
			006	AMINOSYN 7% (PH6)	INJECTABLE;INJECTION	7% (7GM/100ML)	AMINO ACIDS	1975-12-03	Discontinued	No
			004	AMINOSYN 8.5%	INJECTABLE;INJECTION	8.5% (8.5GM/100ML)	AMINO ACIDS	1975-12-03	Discontinued	No
			007	AMINOSYN 8.5% (PH6)	INJECTABLE;INJECTION	8.5% (8.5GM/100ML)	AMINO ACIDS	1975-12-03	Discontinued	No
			005	AMINOSYN 8.5% W/ ELECTROLYTES	INJECTABLE;INJECTION	8.5%;102MG/100ML;522MG/100ML;410MG/100ML	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE	1975-12-03	Discontinued	No
			009	AMINOSYN 8.5% W/ELECTROLYTES	INJECTABLE;INJECTION	8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100ML	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC	1975-12-03	Discontinued	No