Application 016673

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	5GM/100ML	Yes	Yes
003	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	50MG/ML	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0017	DEXTROSE	DEXTROSE MONOHYDRATE	Baxter Healthcare Corporation	NDA	Current
0338-0017	DEXTROSE	DEXTROSE MONOHYDRATE	Baxter Healthcare Corporation	NDA	Current
0338-0017	DEXTROSE	DEXTROSE MONOHYDRATE	Baxter Healthcare Corporation	NDA	Current
0338-0017	DEXTROSE	DEXTROSE MONOHYDRATE	Baxter Healthcare Corporation	NDA	Current
0338-0017	DEXTROSE	DEXTROSE MONOHYDRATE	Baxter Healthcare Corporation	NDA	Current
0338-0017	DEXTROSE	DEXTROSE MONOHYDRATE	Baxter Healthcare Corporation	NDA	Current
0338-0017	DEXTROSE	DEXTROSE MONOHYDRATE	Baxter Healthcare Corporation	NDA	Current
0338-0062	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0062	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0062	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0062	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0062	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0062	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0062	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0066	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0066	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0066	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0066	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0066	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0066	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0066	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0070	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0070	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0070	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0070	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0070	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0070	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0070	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0074	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0074	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0074	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0074	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0074	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0074	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0074	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0078	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0078	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0078	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0078	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0078	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0078	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0078	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0082	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0082	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0082	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0082	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0082	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0082	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0082	DEXTROSE	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-6346	Dextrose	Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-6346	Dextrose	Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-6346	Dextrose	Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
55154-2885	DEXTROSE	DEXTROSE MONOHYDRATE	Cardinal Health	NDA	Current
55154-2886	DEXTROSE	DEXTROSE MONOHYDRATE	Cardinal Health	NDA	Current
55154-2887	DEXTROSE	DEXTROSE MONOHYDRATE	Cardinal Health	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81785	SUPPL	2025-03-31
81783	SUPPL	2025-03-31
59725	SUPPL	2019-08-15
59584	SUPPL	2019-08-06
10905	SUPPL	2015-01-09
472	SUPPL	2014-12-24

Application 016673

Related Records#

Application Products#

NDC Listings For This Application#

Documents#