FDA.reportPublic FDA data

Application 072034

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROGLYCERINNITROGLYCERININJECTABLE;INJECTION5MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9928NitroglycerinNitroglycerinHenry Schein, Inc.ANDACurrent
0404-9928NitroglycerinNitroglycerinHenry Schein, Inc.ANDACurrent
0517-4810NitroglycerinnitroglycerinAmerican Regent, Inc.ANDACurrent
0517-4810NitroglycerinnitroglycerinAmerican Regent, Inc.ANDACurrent
0517-4810NitroglycerinnitroglycerinAmerican Regent, Inc.ANDACurrent
51662-1386NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1386NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-810NitroglycerinNitroglycerinGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-810NitroglycerinNitroglycerinGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-810NitroglycerinNitroglycerinGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-810NitroglycerinNitroglycerinGeneral Injectables and Vaccines, Inc.ANDACurrent