Application 016682

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0117	Lactated Ringers	Sodium chloride, potassium chloride, sodium lactate and calcium chloride	Baxter Healthcare Corporation	NDA	Current
0338-0117	Lactated Ringers	Sodium chloride, potassium chloride, sodium lactate and calcium chloride	Baxter Healthcare Corporation	NDA	Current
0338-0117	Lactated Ringers	Sodium chloride, potassium chloride, sodium lactate and calcium chloride	Baxter Healthcare Corporation	NDA	Current
0338-0117	Lactated Ringers	Sodium chloride, potassium chloride, sodium lactate and calcium chloride	Baxter Healthcare Corporation	NDA	Current
0338-0117	Lactated Ringers	Sodium chloride, potassium chloride, sodium lactate and calcium chloride	Baxter Healthcare Corporation	NDA	Current
70529-025	Lacellate Solution - 250	Sodium chloride, potassium chloride, sodium lactate and calcium chloride	IT3 Medical LLC	NDA	Current
70529-025	Lacellate Solution - 250	Sodium chloride, potassium chloride, sodium lactate and calcium chloride	IT3 Medical LLC	NDA	Current
70529-025	Lacellate Solution - 250	Sodium chloride, potassium chloride, sodium lactate and calcium chloride	IT3 Medical LLC	NDA	Current
70529-026	Lacellate Solution - 500	Sodium chloride, potassium chloride, sodium lactate and calcium chloride	IT3 Medical LLC	NDA	Current
70529-026	Lacellate Solution - 500	Sodium chloride, potassium chloride, sodium lactate and calcium chloride	IT3 Medical LLC	NDA	Current
70529-026	Lacellate Solution - 500	Sodium chloride, potassium chloride, sodium lactate and calcium chloride	IT3 Medical LLC	NDA	Current
70529-027	Lacellate Solution - 1000	Sodium chloride, potassium chloride, sodium lactate and calcium chloride	IT3 Medical LLC	NDA	Current
70529-027	Lacellate Solution - 1000	Sodium chloride, potassium chloride, sodium lactate and calcium chloride	IT3 Medical LLC	NDA	Current
70529-027	Lacellate Solution - 1000	Sodium chloride, potassium chloride, sodium lactate and calcium chloride	IT3 Medical LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84116	SUPPL	2025-11-06
84076	SUPPL	2025-11-06
79225	SUPPL	2024-07-29
79213	SUPPL	2024-07-25
60526	SUPPL	2020-01-23
60514	SUPPL	2019-10-10
33190	SUPPL	2011-11-04
13019	SUPPL	2011-10-24
13018	SUPPL	2003-07-06
479	SUPPL	2002-08-01
13017	SUPPL	2002-04-03