Application 018008

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 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML;450MG/100ML	No	No
002	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML;450MG/100ML	No	No
003	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;224MG/100ML;450MG/100ML	No	No
004	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML;450MG/100ML	No	No
005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML;450MG/100ML	No	No
006	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML;450MG/100ML	No	No
007	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML;450MG/100ML	No	No
008	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;224MG/100ML;450MG/100ML	No	No
009	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML;450MG/100ML	No	No
010	DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML;450MG/100ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0669	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0669	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0669	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0669	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0671	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0671	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0671	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0671	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0673	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0673	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0673	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0673	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0675	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0675	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0675	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0675	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
57756	SUPPL	2019-02-22
57754	SUPPL	2019-02-22
773	SUPPL	2013-09-12
33388	SUPPL	2013-09-11
772	SUPPL	2007-05-01
33387	SUPPL	2007-04-25
13975	SUPPL	2005-08-31
11109	SUPPL	2005-08-31
771	SUPPL	2004-06-07
13974	SUPPL	2003-05-29