Application 016677

Type: NDA
Sponsor: BAXTER HLTHCARE

Related Records

Company: BAXTER HLTHCARE

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	900MG/100ML	Yes	Yes
003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	SOLUTION;INJECTION	450MG/50ML (9MG/ML)	Yes	Yes
004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	9MG/ML	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0049	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0049	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0049	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0049	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0049	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0049	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0049	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-9529	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9529	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9529	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9529	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9529	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9529	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9537	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9537	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9537	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9537	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9537	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9537	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9543	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9543	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9543	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9543	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9543	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9543	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9543	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
49836-031	LIQUIVIDA HYDRATION	SODIUM CHLORIDE	RX PHARMA-PACK, INC.	NDA	Current
49836-031	LIQUIVIDA HYDRATION	SODIUM CHLORIDE	RX PHARMA-PACK, INC.	NDA	Current
49836-032	LIQUIVIDA HYDRATION	SODIUM CHLORIDE, CHLORHEXIDINE GLUCONATE , ISOPROPYL ALCOHOL	RX PHARMA-PACK, INC.	NDA	Current
49836-032	LIQUIVIDA HYDRATION	SODIUM CHLORIDE, CHLORHEXIDINE GLUCONATE , ISOPROPYL ALCOHOL	RX PHARMA-PACK, INC.	NDA	Current
49836-032	LIQUIVIDA HYDRATION	SODIUM CHLORIDE, CHLORHEXIDINE GLUCONATE , ISOPROPYL ALCOHOL	RX PHARMA-PACK, INC.	NDA	Current
70529-022	Nacellate Solution 0.9% - 250mL	Sodium Chloride	IT3 Medical LLC	NDA	Current
70529-022	Nacellate Solution 0.9% - 250mL	Sodium Chloride	IT3 Medical LLC	NDA	Current
70529-022	Nacellate Solution 0.9% - 250mL	Sodium Chloride	IT3 Medical LLC	NDA	Current
70529-023	Nacellate Solution 0.9% - 500mL	Sodium Chloride	IT3 Medical LLC	NDA	Current
70529-023	Nacellate Solution 0.9% - 500mL	Sodium Chloride	IT3 Medical LLC	NDA	Current
70529-023	Nacellate Solution 0.9% - 500mL	Sodium Chloride	IT3 Medical LLC	NDA	Current
70529-024	Nacellate Solution 0.9% - 1000mL	Sodium Chloride	IT3 Medical LLC	NDA	Current
70529-024	Nacellate Solution 0.9% - 1000mL	Sodium Chloride	IT3 Medical LLC	NDA	Current
70529-024	Nacellate Solution 0.9% - 1000mL	Sodium Chloride	IT3 Medical LLC	NDA	Current

Documents

Document	Submission type	Date
79224	SUPPL	2024-07-29
79212	SUPPL	2024-07-25
58966	SUPPL	2019-06-04
58891	SUPPL	2019-05-30
53075	SUPPL	2018-03-21
53074	SUPPL	2018-03-21
10909	SUPPL	2015-06-03
10908	SUPPL	2015-01-08
475	SUPPL	2014-12-30
10907	SUPPL	2013-09-17
474	SUPPL	2013-09-13
10906	SUPPL	2005-09-07
473	SUPPL	2005-09-07
33189	SUPPL	2005-05-25
13015	SUPPL	2005-05-25
13014	SUPPL	2003-07-28
13013	SUPPL	2002-04-03