Application 017512

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML	No	No
002	DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML	No	No
003	DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML	No	No
004	DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	Yes	No
005	DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	Yes	No
006	DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	Yes	No
007	DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML	No	No
008	DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML	No	No
009	DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML	No	No
010	DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML	No	No
011	DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	Yes	No
012	DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	Yes	No
013	DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	Yes	No
014	DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	Yes	No
015	DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0941-0409	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0409	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0409	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0409	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0409	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0409	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0409	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0409	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0409	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corpora	NDA	Current
0941-0409	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0411	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0411	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0411	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corpora	NDA	Current
0941-0411	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0411	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0411	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0411	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0411	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0411	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0411	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0413	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0413	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0413	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0413	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0413	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0413	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0413	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corpora	NDA	Current
0941-0413	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0413	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0413	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0415	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0415	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0415	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0415	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0415	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0415	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0415	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0415	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corpora	NDA	Current
0941-0415	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0415	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0457	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0457	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0457	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0457	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0457	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0457	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0457	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corpora	NDA	Current
0941-0457	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0457	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0457	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0459	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0459	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0459	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0459	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0459	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0459	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0459	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0459	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corpora	NDA	Current
0941-0459	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0459	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0484	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0484	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0484	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0484	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0484	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0484	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0484	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corpora	NDA	Current
0941-0484	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0484	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0484	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0487	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0487	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0487	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0487	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0487	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0487	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0487	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0487	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corpora	NDA	Current
0941-0487	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0487	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45138	SUPPL	2016-08-16
45137	SUPPL	2016-08-16
45136	SUPPL	2016-08-16
45135	SUPPL	2016-08-16
45134	SUPPL	2016-08-16
45133	SUPPL	2016-08-16
11005	SUPPL	2015-09-04
610	SUPPL	2015-09-04
13162	SUPPL	2015-07-31
609	SUPPL	2015-07-31
33289	SUPPL	2015-07-30
11004	SUPPL	2015-07-30
33288	SUPPL	2015-02-10
13161	SUPPL	2015-02-10
608	SUPPL	2013-04-24
11003	SUPPL	2013-04-23
11002	SUPPL	2009-01-02
13160	SUPPL	2008-12-24
607	SUPPL	2005-08-11
606	SUPPL	2005-08-11

Application 017512

Related Records#

Application Products#

NDC Listings For This Application#

Documents#