Application 020171

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% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	No	No
002	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	No	No
003	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	18.4MG/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
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-206	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-209	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	DELFLEX	Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride	Fresenius Medical Care North America	NDA	Current
49230-212	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
66008	SUPPL	2021-01-27
12297	SUPPL	2015-01-12
2137	SUPPL	2015-01-09
34340	SUPPL	2014-04-28
2136	SUPPL	2014-04-25
34339	SUPPL	2013-04-19
2135	SUPPL	2013-02-04
12296	SUPPL	2013-02-01
2134	SUPPL	2009-11-13
21256	SUPPL	2003-12-02

Application 020171

Related Records#

Application Products#

NDC Listings For This Application#

Documents#