Application 018629

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML;330MG/100ML	No	No
002	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML;330MG/100ML	No	No
003	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;224MG/100ML;330MG/100ML	No	No
004	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML;330MG/100ML	No	No
005	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML;330MG/100ML	No	No
006	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML;330MG/100ML	No	No
007	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;224MG/100ML;330MG/100ML	No	No
008	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML;330MG/100ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0603	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0603	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0603	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0603	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58036	SUPPL	2019-03-19
57758	SUPPL	2019-02-22
54943	SUPPL	2018-07-23