Application 018883

Type: NDA
Sponsor: FRESENIUS MEDCL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DELFLEX 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	DELFLEX 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
003	DELFLEX 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
004	DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM 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	No	No
005	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM 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	No	No
006	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM 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	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49230-188	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-188	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current
49230-188	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current
49230-188	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-188	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-188	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-188	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-188	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-188	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-188	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-188	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-188	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-191	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current
49230-191	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-191	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-191	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-191	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-191	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-191	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-191	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-191	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-191	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-191	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-191	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current
49230-194	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current
49230-194	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current
49230-197	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current
49230-197	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current
49230-200	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current
49230-200	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current
49230-203	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current
49230-203	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66007	SUPPL	2021-01-27
11356	SUPPL	2015-01-12
1116	SUPPL	2015-01-09
33633	SUPPL	2014-04-28
1115	SUPPL	2014-04-25
33632	SUPPL	2013-04-19
16080	SUPPL	2013-02-04
33631	SUPPL	2013-02-01
1114	SUPPL	2009-11-13
16079	SUPPL	2003-12-02

Application 018883

Related Records#

Application Products#

NDC Listings For This Application#

Documents#