FDA.reportPublic FDA data

Application 086925

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE DINITRATEISOSORBIDE DINITRATETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8157Isosorbide Dinitrateisosorbide dinitrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43353-139Isosorbide Dinitrateisosorbide dinitrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
49884-021Isosorbide Dinitrateisosorbide dinitratePar Pharmaceutical, Inc.ANDACurrent
49884-021Isosorbide Dinitrateisosorbide dinitratePar Pharmaceutical, Inc.ANDACurrent
49884-021Isosorbide Dinitrateisosorbide dinitratePar Pharmaceutical, Inc.ANDACurrent
49884-021Isosorbide Dinitrateisosorbide dinitratePar Pharmaceutical, Inc.ANDACurrent
49884-021Isosorbide Dinitrateisosorbide dinitratePar Pharmaceutical, Inc.ANDACurrent
50268-448Isosorbide DinitrateIsosorbide DinitrateAvPAKANDACurrent
50268-448Isosorbide DinitrateIsosorbide DinitrateAvPAKANDACurrent
60429-441Isosorbide Dinitrateisosorbide dinitrateGolden State Medical Supply, Inc.ANDACurrent
60429-441Isosorbide Dinitrateisosorbide dinitrateGolden State Medical Supply, Inc.ANDACurrent
63739-569Isosorbide Dinitrateisosorbide dinitrateMcKesson CorporationANDACurrent
63739-569Isosorbide Dinitrateisosorbide dinitrateMcKesson Corporation dba SKY PackagingANDACurrent
63739-569Isosorbide Dinitrateisosorbide dinitrateMcKesson Corporation dba SKY PackagingANDACurrent
63739-569Isosorbide Dinitrateisosorbide dinitrateMcKesson Corporation dba SKY PackagingANDACurrent
68084-082Isosorbide DinitrateIsosorbide DinitrateAmerican Health PackagingANDACurrent
68084-082Isosorbide DinitrateIsosorbide DinitrateAmerican Health PackagingANDACurrent
68084-082Isosorbide DinitrateIsosorbide DinitrateAmerican Health PackagingANDACurrent
68084-082Isosorbide DinitrateIsosorbide DinitrateAmerican Health PackagingANDACurrent
68084-082Isosorbide DinitrateIsosorbide DinitrateAmerican Health PackagingANDACurrent
70518-2817Isosorbide Dinitrateisosorbide dinitrateREMEDYREPACK INC.ANDACurrent
70518-2817Isosorbide Dinitrateisosorbide dinitrateREMEDYREPACK INC.ANDACurrent