Application 021703

Type: NDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	Yes	No
002	PRISMASOL BGK 2/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	Yes	Yes
003	PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	Yes	Yes
004	PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	Yes	Yes
005	PRISMASOL BGK 4/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	No	No
006	PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	Yes	Yes
007	PRISMASOL BK 0/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	No	No
008	PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	No	No
009	PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	No	No
010	PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	Yes	No
011	PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	Yes	Yes
012	PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	No	No
013	PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	Yes	No
014	PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	Yes	Yes
015	PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24571-102	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-102	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-102	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-102	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-102	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-102	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-102	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-103	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-103	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-103	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-103	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-103	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-103	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-103	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-105	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-105	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-105	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-105	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-105	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-105	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-105	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-108	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-108	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-108	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-108	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-108	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-108	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-108	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-111	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-111	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-111	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-111	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-111	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-111	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-111	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-113	PRISMASOL	magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-113	PRISMASOL	magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-113	PRISMASOL	magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-113	PRISMASOL	magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-113	PRISMASOL	magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-113	PRISMASOL	magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-113	PRISMASOL	magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-114	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-114	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-114	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-114	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-114	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-114	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-114	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74160	SUPPL	2023-05-03
74157	SUPPL	2023-05-03
56244	SUPPL	2018-12-06
56295	SUPPL	2018-11-06
48905	SUPPL	2017-07-05
48890	SUPPL	2017-07-03
6021	SUPPL	2016-07-22
37490	SUPPL	2016-07-21
37489	SUPPL	2015-12-17
28415	SUPPL	2015-12-17
28414	SUPPL	2013-06-12
16228	SUPPL	2012-04-17
6020	SUPPL	2012-04-16
16227	SUPPL	2009-04-28
37488	SUPPL	2008-11-07
28413	SUPPL	2008-10-22
42276	ORIG	2008-04-22
28412	ORIG	2006-10-27
16226	ORIG	2006-10-26

Application 021703

Related Records#

Application Products#

NDC Listings For This Application#

Documents#