Application 019970

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROGLYCERIN IN DEXTROSE 5%	NITROGLYCERIN	INJECTABLE;INJECTION	10MG/100ML	Yes	Yes
002	NITROGLYCERIN IN DEXTROSE 5%	NITROGLYCERIN	INJECTABLE;INJECTION	20MG/100ML	Yes	Yes
003	NITROGLYCERIN IN DEXTROSE 5%	NITROGLYCERIN	INJECTABLE;INJECTION	40MG/100ML	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-1047	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1047	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1047	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1047	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1047	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1049	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1049	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1049	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1049	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1049	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1051	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1051	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1051	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1051	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1051	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
51662-1332	NITROGLYCERIN IN DEXTROSE	NITROGLYCERIN, DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1332	NITROGLYCERIN IN DEXTROSE	NITROGLYCERIN, DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1332	NITROGLYCERIN IN DEXTROSE	NITROGLYCERIN, DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1332	NITROGLYCERIN IN DEXTROSE	NITROGLYCERIN, DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45109	SUPPL	2016-08-23
45155	SUPPL	2016-08-22
34169	SUPPL	2014-10-03
1879	SUPPL	2014-10-03