Application 019437

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
004	AMINOSYN II 10% W/ ELECTROLYTES	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE	INJECTABLE;INJECTION	10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML	No	No
005	AMINOSYN II 8.5% W/ ELECTROLYTES	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE	INJECTABLE;INJECTION	8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML	No	No
006	AMINOSYN II 7% W/ ELECTROLYTES	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE	INJECTABLE;INJECTION	7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML	No	No
007	AMINOSYN II 3.5% M	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	INJECTABLE;INJECTION	3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML	No	No
008	AMINOSYN II 8.5% W/ELECTROLYTES	AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC	INJECTABLE;INJECTION	8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-4171	Aminosyn II with Electrolytes	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, ALANINE, ARGI	Hospira, Inc.	NDA	Current

Document, Submission type, Date table
Document	Submission type	Date
17404	SUPPL	2004-05-27
17403	SUPPL	2003-07-06