Application 209376

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRALEMENT	TRACE ELEMENTS	INJECTABLE;INJECTION	1ML	Yes	No
002	TRALEMENT	CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE	SOLUTION;INTRAVENOUS	(5ML) EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG BASE/ML;EQ 3MG BASE/ML	Yes	No
003	TRALEMENT	CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE	SOLUTION;INTRAVENOUS	(1ML) EQ 0.06MG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG BASE/ML;EQ 1MG BASE/ML	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-9302	Multrys	Trace Elements Injection 4	American Regent, Inc.	NDA	Current
0517-9305	Tralement	Trace Elements Injection 4	American Regent, Inc.	NDA	Current
0517-9305	Tralement	Trace Elements Injection 4	American Regent, Inc.	NDA	Current
0517-9305	Tralement	Trace Elements Injection 4	American Regent, Inc.	NDA	Current